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FIELD CORRECTIVE ACTION LISTING FOR MAY, JUNE AND JULY 2023
The list below contains Medical Device’s Field Corrective Action for the month of May, June and July 2023. This list provides field corrective action reporting information to MDA by establishment in accordance to requirement stipulated in Section 41, Act 737 and Regulation 6 of Medical Device (Duties and Obligations of Establishment) Regulations 2019.
Field Corrective Action (FCA) is part of a post-marketing risk assessment measure to ensure the continued safe use of medical devices in the Malaysia market. It is a corrective or preventive action in relation to a medical device which may include –
(a) The return of the medical device to the establishment;
(b) Modification of the medical device;
(c) Exchange of the medical device;
(d) Destruction of medical device; or
(e) Specific advice on the use of the medical device.
If you have experienced any safety and performance issue with one of the medical devices listed for FCA action, please seek advice from your medical device authorised representative as soon as possible.
|
Date received |
Title of FCA |
Affected Medical Device |
MDA Reference Number |
MDA Registration Number |
Description |
Local Establishment Contact Detail |
|
31 May 2023 |
FA30MAY2023-REC Alinity ci-series System Control Module (SCM) Product Correction |
ALINITY I PROCESSING MODULE |
MDA/FCA/P0380-41571770-2023 |
IVDA3247720-46201 |
Abbott has identified potential performance issues found in the Alinity ci‐series System software versions 3.4.0 and lower. |
VIOLA SUBHASHINI PETERS REGULATORY AFFAIRS & QUALITY ASSURANCE MANAGER ABBOTT LABORATORIES (MALAYSIA) SDN. BHD. |
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2 June 2023 |
AFINION 2 |
MDA/FCA/P0382-68973741-2023 |
IVD27240868318A |
Abbott has identified an issue related to overheating of Afinion 2 instruments with software version ≤ 21.13. |
VIOLA SUBHASHINI PETERS REGULATORY AFFAIRS & QUALITY ASSURANCE MANAGER ABBOTT LABORATORIES (MALAYSIA) SDN. BHD. |
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18 July 2023 |
HOYA VIVINEX MULTISERT PRELOADED INTRAOCULAR LENS |
MDA/FCA/P0416-11022182-2023 |
GC3393421-63214 |
Between 22 May and 12 June 2023, HOYA Surgical Optics has received 20 complaints of rapid IOL release from injectors while using Push Plunger Option to implant the lenses, which in some cases led to the capsular bag rupture. |
NURAISYAH BINTI AHMAD SHUKRI REGULATORY AFFAIRS & QUALITY ASSSURANCE SPECIALIST ANDAMAN MEDICAL BRIDGE SDN. BHD. |
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14 June 2023 |
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DxA Automation System |
MDA/FCA/P0398-85658873-2023 |
IVDA6616722-91768 |
The software Remisol, which is installed on the DxA Automation system, has a feature called “Take Account of Route Plan,” which is designed to receive information from DxA Automation System on test orders to be executed on an analyzer. |
NUR AISHAH BINTI ABD AZIZ RA SPECIALIST BECKMAN COULTER MALAYSIA SDN. BHD. |
|
3 July 2023 |
FA-23027 - Issue associated with the
|
THYROID FUNCTION MARKERS |
MDA/FCA/P0420-41492741-2023 |
IVDB7247723-115154 |
On 2023-June-28 Beckman Coulter made the decision to conduct a field action on Access Thyroglobulin Calibrators. In April 2023, Beckman Coulter distributed a letter that provided alternate Access Thyroglobulin calibrator cards for use with the Thyg reagent packs |
NUR AISHAH BINTI ABD AZIZ RA SPECIALIST BECKMAN COULTER MALAYSIA SDN. BHD. |
|
18 July 2023 |
AU IMMUNOGLOBULINS |
MDA/FCA/P0432-38048408-2023 |
IVDB10153022-90807 |
On 12th July 2023 Beckman Coulter made the decision to conduct a field action on IgA OSR61171. Beckman Coulter has identified that the lipemic interference for the IgA serum application failed to meet the performance specification as defined in the IgA IFU. |
NUR AISHAH BINTI ABD AZIZ RA SPECIALIST BECKMAN COULTER MALAYSIA SDN. BHD. |
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1 June 2023 |
PHADIA AB_ IMMUNOCHEMISTRY_ AUTO-IMMUNE DISEASES |
MDA/FCA/P0381-53514376-2023 |
IVDB43283287718 |
Several customer complaints have been reported where specific samples produced false positive EliA GBM results. An investigation confirmed that a positive signal was present when these samples were tested for coating-solution reactivity using EliA wells without antigen. |
APPHIA EU CHIA HUI SENIOR REGULATORY & QA BIOMARKETING SERVICES (M) SDN BHD |
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2 May 2023 |
VIDAS® FERTILITY PANEL |
MDA/FCA/P0210-43049481-2023 |
IVDB65439141618 |
bioMérieux received nine (9) complaints from three (3) different customers, regarding MUELLER HINTON E AGAR 90 100PL (reference 413824 and 413822) as ATCC 27853 Pseudomonas aeruginosa and Gentamicin disk (Oxoid) and ETEST® method did not pass quality control (QC) |
RUHIL ASHVIN KUMAR ASEAN QA/RA MANAGER BIOMERIEUX MALAYSIA SDN BHD |
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16 June 2023 |
GA61061-2-FLEX MONOCLONAL MOUSE ANTI HUMAN CD31- ERROR IN GERMAN SECTION OF IFU |
DAKO PRIMARY ANTIBODIES (LIVER, BILIARY SYSTEM AND EXOCRINE PANCREAS) |
MDA/FCA/P0364-94537442-2023 |
IVDC57625345918 |
Based on investigations, the mismatch between CD31 and CD10 instructions is deemed to be recognizable and apparent to users. Therefore, there is little risk to patients or users. Advise user to refer on latest IFU |
HOW KIAN MING MANAGING DIRECTOR BITA LIFESCIENCE SDN. BHD. |
|
10 May 2023 |
False Negative Result to LIFECODES® HLA-DQA1/B1 SSO Typing Kit (identifier: 628930) (lot #3012778) |
LIFECODES HLA SSO TYPING KITS |
MDA/FCA/P0334-73308123-2023 |
IVDC1630019117 |
Immucor, GTI Diagnostics, Inc has determined that the threshold set for LIFECODES HLA-DQA1/B1 SSO Typing Kit probe DQA207 lot 3012778 threshold was artificially elevated. This may result in a false negative assignment for probe DQA207. |
APPHIA EU CHIA HUI SENIOR REGULATORY & QA BMS DIAGNOSTICS (M) SDN BHD |
|
24 May 2023 |
|
HEMOSTASIS DEVICE |
MDA/FCA/P0359-55075262-2023 |
GB475001118818 |
The current Hemospray Instructions for Use states, “Potential Complications: When spraying in the retroflexed position, Hemospray powder may adhere to the outside of the endoscope. This may result in difficulty repositioning/ removing the endoscope, particularly if passing through a strictured area. |
CHONG SINN HUEI (CLAIRE) REGULATORY AFFAIRS SPECIALIST COOK ASIA (MALAYSIA) SDN BHD |
|
22 May 2023 |
GAS THERAPY UNIT NO-A EKU |
MDA/FCA/P0360-63375665-2023 |
GB81161650618 |
When operating the NO therapy device, NO-A (manufacturer: EKU Elektronik GmbH) together with the Servo-n resp. Servo-u ventilators in neonatal mode (manufacturer: Getinge), it can happen in certain cases that too little nitric oxide (NO) is delivered by the device and therefore the NO concentration produced is significantly lower than specified by the user. |
BEATRICE MAH WAN XIN QUALITY AND REGULATORY AFFAIR SPECIALIST DRAEGER MALAYSIA SDN BHD |
|
|
27 June 2023 |
Carina - Potential contamination of breathing gas - replacement of blower cover |
SUB-ACUTE CARE VENTILATOR, CARINA |
MDA/FCA/P0415-55653893-2023 |
GC26436820018 |
With a view to determining the long-term stability of the PE-PUR foam used for sound insulation in Carina Ventilators, we subjected devices of different ages of devices to biocompatibility tests |
BEATRICE MAH WAN XIN QUALITY AND REGULATORY AFFAIR SPECIALIST DRAEGER MALAYSIA SDN BHD |
|
22 May 2023 |
FDR NANO |
MDA/FCA/P0337-38752606-2023 |
GC9504922-113649 |
We received a report that the arm part wobbled while moving this device and that an arm broke during arm movement. Then, in DR-XD 1000, incorrect mirror installation inside the Collimator Assembly causes a deficiency where the LED light does not reach the vicinity of the full open area of Light Irradiation Field and the device is unable to properly irradiate the Light Irradiation Field. |
NUR IRYANI BINTI MOHD YUSOF REGULATORY AFFAIRS OFFICER - MEDICAL SYSTEMS FUJIFILM (MALAYSIA) SDN. BHD. |
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|
23 May 2023 |
CASE CARDIAC TESTING SYSTEM |
MDAFCAP0363-28990428-2023 |
GB64876396017 |
Full Vision recently became aware that certain Full Vision medical treadmills (see Table 1 affected products section of Full Vision's FSN letter) may accelerate forwards or backwards without notice. |
LIM SOCK SIANG DIRECTOR GE HEALTHCARE SDN. BHD |
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29 May 2023 |
GIRAFFE OMNIBED CARESTATION CS1 |
MDA/FCA/P0373-63660915-2023 |
GC36600486117 |
GE HealthCare has become aware of the potential that an incorrect type of secondary latch could have been installed on the northeast (NE) and/or northwest (NW) bedside panels for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices (see figure 1 in FSN, Attachment 02). |
LIM SOCK SIANG DIRECTOR GE HEALTHCARE SDN. BHD |
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|
6 June 2023 |
Flexiview 8800, OEC 9800, OEC 9900 and OEC Elite systems with 9-inch Image Intensifier |
OEC 9900 ELITE |
MDA/FCA/P0383-28227812-2023 |
GC94344706818 |
GE HealthCare has become aware that the 9-inch Image Intensifier for OEC Flexiview 8800, OEC 9800, OEC 9900 and OEC Elite systems can become detached if the systems encounter a large impact force when moved. |
LIM SOCK SIANG DIRECTOR GE HEALTHCARE SDN. BHD |
|
9 June 2023 |
B105P/B105M/B125P/ B125M/B155M PATIENT MONITOR |
MDA/FCA/P0392-73589485-2023 |
GC3218021-63208 |
Affected TruSignal SpO2 Sensors (see Table 1 in FSN) can potentially reduce the amount of electrical energy reaching the patient during external defibrillation, which could limit successful defibrillation and restoration of a normal rhythm. |
LIM SOCK SIANG DIRECTOR GE HEALTHCARE SDN. BHD |
|
|
9 June 2023 |
VIVID S SERIES (S60N, S70N) |
MDA/FCA/P0393-17367616-2023 |
GB48228729218 |
GE HealthCare has become aware that certain Vivid ultrasound systems may not boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations. |
LIM SOCK SIANG DIRECTOR GE HEALTHCARE SDN. BHD |
|
|
5 July 2023 |
ELECTROSURGICAL SYSTEM |
MDA/FCA/P0418-53124439-2023 |
GC2965522-109913 |
Megadyne has received complaints of patient burns while using Mega Soft return electrode pads. The thermal injuries ranged from superficial (first degree) to full thickness (third degree) based on photo presentations. |
YAP KWAI LING ASSOCIATE MANAGER, REGULATORY AFFAIRS JOHNSON & JOHNSON SDN BHD |
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16 May 2023 |
FA1326 Increased Potential for Reduced or No Energy Delivered When Programmed AX>B |
AMPLIA MRI™ CRT-D SURESCAN™ |
MDA/FCA/P0344-85783181-2023 |
GD6940123-128555 |
In specific instances, for the identified devices, Medtronic has confirmed that an increased potential for a reduced-energy shock may occur when all the following conditions are met: - The device utilizes a specific feedthrough design implemented after July 2017. - Significant separation of the layers of insulation materials in the feedthrough components of the device header is present. - Formation of an unintended current pathway within the void created by the insulation separation, capable of conducting high levels of current during HV therapy in the AX>B configuration. |
CHOW SOON YEE REGULATORY AFFAIRS LEAD MEDTRONIC MALAYSIA SDN BHD |
|
16 May 2023 |
FA1326 Increased Potential for Reduced or No Energy Delivered When Programmed AX>B |
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |
MDA/FCA/P0348-89984036-2023 |
GD94170903318 |
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16 May 2023 |
FA1326 Increased Potential for Reduced or No Energy Delivered When Programmed AX>B |
BRAVA™ CRT-D |
MDA/FCA/P0349-19819465-2023 |
GD6217023-129887 |
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16 May 2023 |
FA1326 Increased Potential for Reduced or No Energy Delivered When Programmed AX>B |
CLARIA MRI™ CRT-D SURESCAN™ |
MDA/FCA/P0350-25137421-2023 |
GD6499723-125071 |
||
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16 May GD6616723-127042023 |
FA1326 Increased Potential for Reduced or No Energy Delivered When Programmed AX>B |
COMPIA MRI™ CRT-D SURESCAN™ |
MDA/FCA/P0351-34965413-2023 |
GD5564523-125795 |
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16 May 2023 |
FA1326 Increased Potential for Reduced or No Energy Delivered When Programmed AX>B |
EVERA™ ICD |
MDA/FCA/P0352-26106750-2023 |
EVERA™ ICD |
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16 May 2023 |
FA1326 Increased Potential for Reduced or No Energy Delivered When Programmed AX>B |
EVERA MRI FAMILY HP ICD |
MDA/FCA/P0353-76098108-2023 |
GD27530900518 |
||
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16 May 2023 |
FA1326 Increased Potential for Reduced or No Energy Delivered When Programmed AX>B |
PRIMO MRI™ ICD SURESCAN™ |
MDA/FCA/P0354-98870715-2023 |
GD6324523-127043 |
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16 May 2023 |
FA1326 Increased Potential for Reduced or No Energy Delivered When Programmed AX>B |
VISIA AF |
MDA/FCA/P0355-69423696-2023 |
GD23160553618 |
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16 May 2023 |
FA1326 Increased Potential for Reduced or No Energy Delivered When Programmed AX>B |
MIRRO MRI SURESCAN |
MDA/FCA/P0356-42192785-2023 |
GD150491280719 |
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8 June 2023 |
FA1332 Rev B: Missing eIFUs on the Medtronic Manual Website_GD3515119-34251 |
MELODY TRANSCATHETER PULMONARY VALVE AND ENSEMBLE II TRANSCATHETER VALVE DELIVERY SYSTEM |
MDA/FCA/P0388-46674407-2023 |
GD3515119-34251 |
CAPA 577916 was opened by the Global Regulatory Shared Services team (GRSS) to standardize the process for releasing electronic Instructions for Use (e-IFU’s) to the Medtronic e-Manuals website after Regulatory approval is received and/or new revisions to the e-IFU’s are made, before new product/product changes are released |
CHOW SOON YEE REGULATORY AFFAIRS LEAD MEDTRONIC MALAYSIA SDN BHD |
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8 June 2023 |
FA1332 Rev B: Missing eIFUs on the Medtronic Manual Website_GD8317122-94354 |
EVOLUT™ PRO+ SYSTEM |
MDA/FCA/P0389-33588479-2023 |
GD8317122-94354 |
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8 June 2023 |
FA1332 Rev B: Missing eIFUs on the Medtronic Manual Website_GD9231422-89483 |
COREVALVE™ EVOLUT™ PRO SYSTEM |
MDA/FCA/P0390-21173662-2023 |
GD9231422-89483 |
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8 June 2023 |
FA1332 Rev B: Missing eIFUs on the Medtronic Manual Website_GD9589822-93678 |
COREVALVE™ EVOLUT™ R SYSTEM |
MDA/FCA/P0391-67853666-2023 |
GD9589822-93678 |
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4 July 2023 |
EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM |
MDA/FCA/P0425-84305648-2023 |
GC2869522-88521 |
In a 3-year period between 01-May-2019 and 30-Apr-2022 there were eighty-seven (87) reported occurrences of partial stent deployments (0.049% occurrence rate). This occurrence rate is below the rate predicted in product risk management documentation. |
CHOW SOON YEE REGULATORY AFFAIRS LEAD MEDTRONIC MALAYSIA SDN BHD |
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28 July 2023 |
FA1341 Rev A: Missing eIFUs on the Medtronic Manual Website_GD5728623-127029 |
AZURE™ MRI IPG SURESCAN™ |
MDA/FCA/P0438-51975388-2023 |
GD5728623-127029 |
In some regions, Medtronic has received approval to distribute product that includes only electronic Instructions for Use (eIFU) instead of physical Instructions for Use (IFU). In these cases, the product package includes an insert with instructions for how to access the IFU from the Medtronic eManuals website. |
CHOW SOON YEE REGULATORY AFFAIRS LEAD MEDTRONIC MALAYSIA SDN BHD |
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12 June 2023 |
Ultrasound Gel And Ecg Gel Was Reported Contamination Of Bacteria Burkholderia Cepacia. |
TRANSMISSION GEL |
MDA/FCA/P0119-22257574-2022 |
GA13780404317 |
MyMedic had used RO Water System that will reduces particles like dirt, dust and rust, volatile organic compounds (VOCs), chlorine, other contaminants that give water a bad taste or odor and it removes up to 98% of total dissolved solids. |
MOHAMAD FARKHAN BIN DAMRI ASST MANAGER MYMEDIC INNOVATION SDN BHD |
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5 July 2023 |
3 WAY STOPCOCK |
MDA/FCA/P0292-20806306-2023 |
GMD17462371817A |
The Mymedic 3 Way Stopcock (red) was reported having loose thread, the inability to lock well when installed with the umbilical catheter device and causing the back flow. |
MOHAMAD FARKHAN BIN DAMRI ASST MANAGER MYMEDIC INNOVATION SDN BHD |
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23 June 2023 |
Field Safety Notice for ICELOCK® RATCHET due to a lock release issue |
Ossur Icelock Prosthesis suspension system |
MDA/FCA/P0407-79126426-2023 |
GA8550621-59614 |
Össur has received reports where the Icelock 621 inadvertently releases the locking pin and attached liner in the prosthesis, causing the prosthesis to disengage from the patient. 3 serious and 4 minor injuries have been reported due to this product failure. |
BHARAT KUMAR A/L VRAJLAL PREMCHAND DIRECTOR NYPRAX BUSINESS SOLUTIONS |
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13 June 2023 |
Bronchofiberscope, Bronchovideoscope; FSN for BF scopes using in combination with laser devices |
EVIS EXERA III BRONCHOVIDEOSCOPE SYSTEM |
MDA/FCA/P0371-96698624-2023 |
GB58878308917 |
Issue a Field Safety Notice instructing users on what lasers are compatible with the BF series scopes and that use of noncompatible lasers can result in patient injury or death. |
YEOH SEO CHING, SHELLY MANAGER, QUALITY ASSURANCE & REGULATORY AFFAIRS OLYMPUS (MALAYSIA) SDN. BHD. |
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13 June 2023 |
Bronchofiberscope, Bronchovideoscope; FSN for BF scopes using in combination with laser devices |
EVIS LUCERA ELITE BRONCHOVIDEOSCOPE SYSTEM |
MDA/FCA/P0374-92964048-2023 |
GB66358142517 |
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13 June 2023 |
Bronchofiberscope, Bronchovideoscope; FSN for BF scopes using in combination with laser devices |
OPTERA VIDEO SYSTEM |
MDA/FCA/P0375-55466989-2023 |
GB15542818418 |
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13 June 2023 |
Bronchofiberscope, Bronchovideoscope; FSN for BF scopes using in combination with laser devices |
EVIS EXERA II BRONCHOVIDEOSCOPE |
MDA/FCA/P0376-91250047-2023 |
GB97717930218 |
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13 June 2023 |
Bronchofiberscope, Bronchovideoscope; FSN for BF scopes using in combination with laser devices |
BRONCHOFIBERSCOPE |
MDA/FCA/P0377-26213900-2023 |
GB2458719-30851 |
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9 June 2023 |
Information on additional Caution in Instructions for Use (IfU) |
HF-RESECTION ELECTRODE FOR TURIS (STERILE) |
MDA/FCA/P0394-69397387-2023 |
GC22496930518 |
Manufacturer initiated this FSCA after receiving complaints where the loop wire at the distal end of the HF resection electrode broke after getting in contact with metal objects, such as other endoscopic equipment, implants or stents. As a result, fragments can fall inside the patient and must be retrieved. |
YEOH SEO CHING, SHELLY MANAGER, QUALITY ASSURANCE & REGULATORY AFFAIRS OLYMPUS (MALAYSIA) SDN. BHD. |
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9 June 2023 |
Information on additional Caution in Instructions for Use (IfU) |
HF-RESECTION ELECTRODE (STERILE) |
MDA/FCA/P0399-27131233-2023 |
GC69887405217 |
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27 June 2023 |
Information on additional Caution in Instructions for Use (IfU). |
HF-RESECTION ELECTRODE (REUSABLE) |
MDA/FCA/P0413-50207073-2023 |
GC18476930018 |
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25 July 2023 |
Information on additional Caution in Instructions for Use (IfU). |
HF-RESECTION ELECTRODE FOR TURIS (REUSABLE) |
MDA/FCA/P0436-57950036-2023 |
GC238321237819 |
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11 July 2023 |
EUS ULTRASONIC VIDEOSCOPE SYSTEM |
MDA/FCA/P0429-66107892-2023 |
GB79514818718 |
During internal testing, Olympus conducted a pre-verification to investigate the damage mechanism of air/water valve (MAJ-1444), which may lead to back flow to the air/water channel of ultrasound scope. |
YEOH SEO CHING, SHELLY MANAGER, QUALITY ASSURANCE & REGULATORY AFFAIRS OLYMPUS (MALAYSIA) SDN. BHD. |
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22 June 2023 |
MOBILE DIAGNOST WDR |
MDA/FCA/P0362-31610045-2023 |
GC94902489117 |
Philips has become aware of a software login issue associated with specific models of MobileDiagnost wDR systems running on Windows 10 operating system preventing use of the system |
ZAM ZARINA BINTI MAT AIL Q&R MANAGER PHILIPS MALAYSIA SDN BERHAD |
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10 June 2023 |
2023-CC-HPM-014 - Intellivue MX40 Patient Monitor Infinite Standby Use Error |
INTELLIVUE MX40 PATIENT WEARABLE MONITOR |
MDA/FCA/P0395-74372362-2023 |
GC47166391817 |
When the MX40 is in Standby mode for an extended period without patient surveillance no monitoring or alarming is available because alarms, as designed, cannot be triggered when the MX40 is in standby mode. |
ZAM ZARINA BINTI MAT AIL Q&R MANAGER PHILIPS MALAYSIA SDN BERHAD |
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10 June 2023 |
ALLURA XPER FD SERIES |
MDA/FCA/P0396-83593463-2023 |
GC59365128817 |
If FlexMove rail fixation bolts become loose or broken, or cracks appear in the carriage, the following issues may occur: •Transversal movements of the C-Arc stop due to false collision detections because of additional friction. •Manual movement of the FlexMove Carriage not possible due to added friction. •Abnormal noise during transversal movement of the C-Arc. •Unstable C-Arc suspension. •Fall of the C-Arc Assembly (1,500 kg), if all bolts in the X-axis would break/get loose. •Drop of the C-Arc Assembly (up to 10cm if C- Arc is at one side of the rail, up to 5 cm if C-Arc is in the center of the rails, and 1.5 cm if the C-Arc is in the Anterior/ Posterior position), if all bolts in the Y-axis would break/get loose. |
ZAM ZARINA BINTI MAT AIL Q&R MANAGER PHILIPS MALAYSIA SDN BERHAD |
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14 July 2023 |
ALLURA XPER FD SERIES |
MDA/FCA/P0430-44208989-2023 |
GC59365128817 |
Philips has become aware of several situations that can result in a loss of availability of the wireless foot switch during a procedure. Identified issues that may result in the wireless foot switch not being available are: •Loss of Bluetooth connection due to interferences from other radio equipment •Battery not fully charged •Battery not holding its charge •Damage in the charger, cable and/or connector of the wireless foot switch |
ZAM ZARINA BINTI MAT AIL Q&R MANAGER PHILIPS MALAYSIA SDN BERHAD |
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22 June 2023 |
Urgent Field Safety Notice QIAstat-Dx® Respiratory SARS-CoV-2 Panel (REF 691214) LOTs |
QIASTAT-DX® RESPIRATORY SARS-COV-2 PANEL |
MDA/FCA/P0368-58204912-2023 |
IVDC10783623-122508 |
QIAGEN has identified a decreased performance reliability rate for specific LOTs of QIAstat-Dx Respiratory SARS-CoV-2 Panel. |
DEBRA ANNE ANTHONY PETER REGULATORY AFFAIRS MANAGER, APAC QIAGEN BIOTECHNOLOGY MALAYSIA SDN BHD |
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29 May 2023 |
MEDICAL DEVICE - FIELD NOTIFICATIONSTERRAD 100NX STERILIZATION SYSTEM (Parts: 10104, 10104-002, 10104-003, 10104-004)
|
ASP STERRAD 100NX STERILIZATION SYSTEM |
MDA/FCA/P0372-68615554-2023 |
GC15247682318 |
This technical bulletin announces new software update for the STERRAD®100NX Legacy systems (non-ALLClear) that use the ETX2 and ETX1 controllers to address the peroxide clearance failure on the DUO cycle in the field. |
FOO YOON MEE ACCOUNT MANAGER RAPHA MEDICAL SDN. BHD. |
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6 June 2023 |
ASP STERRAD NX STERILIZATION SYSTEM |
MDA/FCA/P0384-63155230-2023 |
GC42194698118 |
This technical bulletin releases new software upgrade that applies only to the STERRAD NX® Sterilizer with ALLClear™ Technology and legacy systems upgraded with ALLClear™ Technology. The ALLClear™ system software will be upgraded to version 113421-05 (1134210501) from 113421-04 (1134210408). |
FOO YOON MEE ACCOUNT MANAGER RAPHA MEDICAL SDN. BHD. |
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7 June 2023 |
ASP STERRAD 100NX STERILIZATION SYSTEM |
MDA/FCA/P0386-14894349-2023 |
GC15247682318 |
This Technical Bulletin releases additional maintenance procedures for STERRAD®100NX Legacy and ALLClear Systems to perform during PM intervals and CM calls to minimize the H2O2 Adjustment failure in the field per CAPA-010032 recommendations. |
FOO YOON MEE ACCOUNT MANAGER RAPHA MEDICAL SDN. BHD. |
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8 June 2023 |
MEDICAL DEVICE - FIELD NOTIFICATION AEROFLEX AER AUTOMATIC ENDOSCOPE REPROCESSOR (28000) |
AEROFLEX AUTOMATIC ENDOSCOPE REPROCESSOR (AER) WITH AUTOSURE MRC MONITOR (ASP) |
MDA/FCA/P0387-16234509-2023 |
GC6301321-65296 |
ASP announces release of Aeroflex AER oftware V1135631002 SW upgrade to address following issues: 1. Improve detergent prime feature 2. Allow more time to fill basin with water 3. Improve MRC reagent feature for QC check 4. Improve inline temperature sensor values 5. Improve RFID scan feature for OPA 6. Improve cycle printout feature |
FOO YOON MEE ACCOUNT MANAGER RAPHA MEDICAL SDN. BHD. |
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27 June 2023 |
STERRAD 100NX STERILIZATION SYSTEM (parts: 10104, 10104-002, 10104-003, 10104-004)
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ASP STERRAD 100NX STERILIZATION SYSTEM |
MDA/FCA/P0414-84259588-2023 |
GC15247682318 |
During routine internal testing, one STERRAD 100NX Sterilization system exceeded the radiated emissions limit by approximately five (5) decibel-microvolts per meter in the 120 to 210 megahertz (MHz) range. |
FOO YOON MEE ACCOUNT MANAGER RAPHA MEDICAL SDN. BHD. |
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10 July 2023 |
Difficulty withdrawing the catheter on Advanta V12 Covered Stent System |
ADVANTA V12 COVERED STENT |
MDA/FCA/P0426-52627451-2023 |
GD4200223-128266 |
Over a 4.5-year period, Atrium/Getinge received 86 complaints of the balloon or catheter hub separating from the delivery catheter due to difficulty withdrawing the catheter. Complications resulting from the malfunctions most commonly involved procedure delay, but instances of surgical intervention for component retrieval were also observed. |
HEW SOOK PEI ADMIN MANAGER RBD HEALTHCARE SDN BHD |
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11 May 2023 |
BENCHMARK |
MDA/FCA/P0343-43843545-2023 |
IVDA34982152818 |
The Instrument’s General-Purpose Input/output (GPIO) board’s Printed Circuit Board (PCB) had an electrical short resulting in smoke and fire. Please note that no evacuation was needed and there was no injury to users. |
KOH WAI CHIN SENIOR REGULATORY AFFAIRS SPECIALIST ROCHE DIAGNOSTICS (M) SDN. BHD. |
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5 May 2023 |
Inaccuracy of volume measurement outside the given specifications. |
CARDIOVIT CS-104 |
MDA/FCA/P0338-31699963-2023 |
GB7213620-39610 |
A problem related to accuracy of volume calibration during volume verification procedure which is obliged prior to use of the SP PLUS spirometry sensor has been reported to Ganshorn. The described error pattern shows an inaccuracy of the volume measurement outside the given specifications. |
LIM THIAM HONG DIRECTOR SCHILLER ASIA PACIFIC SDN. BHD. |
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5 May 2023 |
Inaccuracy of volume measurement outside the given specifications. |
SPIROVIT SP-1 G2 |
MDA/FCA/P0339-86856074-2023 |
GB8798922-84934 |
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24 July 2023 |
Field Service Corrective Action for RADSPEED PRO Ceiling Tube Support CH200 / CH200M. |
RADSPEED PRO |
MDA/FCA/P0434-19752427-2023 |
GC4930621-68598 |
The Ceiling Tube Support (CH200 & CH200M) for RADSPEED PRO consists of an X-ray Tube Support Pull-up Section and an X-ray Tube Support Section to which an X-ray tube assembly is mounted, and the tube holding section is secured to the column of the X-ray tube, and the X-ray Tube Support Pull-up Section with eight bolts. It turned out that this bolt could come loose. |
YEONG CHEN WAI SENIOR GENERAL MANAGER SHIMADZU MALAYSIA SDN BHD |
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5 May 2023 |
ATELLICA A-LYTE INTEGRATED MULTISENSOR (IMT NA K CL) |
MDA/FCA/P0340-86475804-2023 |
IVDB99064148418 |
Siemens Healthcare Diagnostics Inc. has confirmed through investigation of customer complaints that A-LYTE Integrated Multisensor (IMT Na K Cl) Lot 120011 may not routinely meet the Instructions For Use (IFU) Onboard Stability Claim of 14 days or 5000 samples. |
LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN BHD |
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18 May 2023 |
039 CN CC 23-03 Invalid Input Data Error when Scanning ADVIA Centaur CP HBsAgII Calibrator Card |
ADVIA CENTAUR® HBSAGII (HBSII) |
MDA/FCA/P0358-77861953-2023 |
IVDD3184923-118240 |
Siemens Healthcare Diagnostics Inc. has confirmed that an invalid input data error occurs when the HBsAgII Assay Kit Lot 98885292 calibrator assigned value card is scanned on the ADVIA Centaur CP system. This issue prevents customers from calibrating and testing with this assay kit lot. |
LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN BHD |
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14 July 2023 |
ATELLICA CH 930 ANALYZER |
MDA/FCA/P0431-56552642-2023 |
IVD34641418218A |
Atellica CH LDL Cholesterol Direct (DLDL), Atellica CH Total Protein II (TP) or Atellica CH Triglycerides (Trig) is the prior test processed. Addition investigation also indicated carryover from Trig_2 into Mg resulting in elevated results. |
LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN BHD |
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26 July 2023 |
ADVIA CHEMISTRY URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) |
MDA/FCA/P0437-16916029-2023 |
IVDB5744320-51063 |
A customer complaint from outside the United States (OUS) reported that enzymatic creatinine_2 (ECRE_2) results may be falsely depressed when processed immediately after Urinary/ Cerebrospinal Fluid Protein (UCFP) on the ADVIA Chemistry XPT analyser. |
LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN BHD |
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28 April 2023 |
Safety information updated in the 525 Oxygen Concentrator IFU 68_5.pdf |
OXYGEN CONCENTRATOR |
MDA/FCA/P0335-85983879-2023 |
GB66945911718 |
The purpose of this Field Safety Notice is to advise that DeVilbiss Healthcare Ltd has updated the IFU on the 525 series oxygen concentrators, used to provide supplemental low flow oxygen therapy in the home, nursing homes, patient care facilities, etc. |
KONG LAI HOONG GENERAL MANAGER SOMNOTEC (M) SDN BHD |
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13 June 2023 |
Malfunction with Hamilton-C1/C2/C3/T1 ventilators when used long term in neonatal patient group 69_5.pdf |
MEDICAL VENTILATOR |
MDA/FCA/P0397-26829644-2023 |
GC25545945118 |
Hamilton Medical become aware of a malfunction with Hamilton C2/C3/C1/T1 ventilators when used long term in neonatal patient group. If an affected device is used accumulatively for 91 days in neonatal patient group without a restart of the device , the device will switch to "Ambient State" and therefore stop ventilation |
NUR DIANA ABD RAZAK HEAD OF QUALITY ASSURANCE STAR MEDIK SDN BHD |
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30 June 2023 |
UPDATED URGENT FIELD SAFETY NOTICE HEMOSIL® LIQUID ANTI-XA, PART NOS. 0020302600 AND 0020302601 ALL LOTS ACL TOP® FAMILY / ACL TOP® FAMILY 50 SERIES
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HEMOSIL LIQUID ANTI-XA |
MDA/FCA/P0416-74146008-2023 |
IVDC53329234618 |
Identified that HemosIL Liquid Anti-Xa (Part Nos. 0020302600 and 0020302601) is not meeting its labeled on-board instrument stability claim for the heparin assay of 7 days at 15-25°C for the ACL TOP Family and ACL TOP Family 50 Series. |
CHAI AI LIN MANAGER STRAITS SCIENTIFIC (M) SDN BHD |
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11 May 2023 |
URGENT PRODUCT CORRECTION NOTIFICATION Potential Bias Observed in VITROS Chemistry Products HbA1c Reagent Kit
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VITROS CHEMISTRY PRODUCTS HBA1C REAGENT KIT |
MDA/FCA/P0341-45294433-2023 |
IVDB38081337018 |
During Ortho’s release testing of Lot 34-1345, an issue was found that up to 6% of reagent packs may generate biased results. Subsequent testing also confirmed atypical drift on results obtained from affected reagent packs. As the issues were detected in the most recent lot, Ortho’s investigation is on-going. |
MENG TSE LEEAU MANAGING DIRECTOR T T MEDICAL MANAGEMENT SDN BHD |
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27 June 2023 |
REVERSE DILUENT CASSETTE |
MDA/FCA/P0412-75816165-2023 |
IVDD33166265118 |
Ortho Clinical Diagnostics, Inc (QuidelOrtho™) internal investigation identified that the regional setting on a small population of ORTHO VISION Analysers was set to “OCD”. This analyser configuration is intended for internal use only. |
MENG TSE LEEAU MANAGING DIRECTOR T T MEDICAL MANAGEMENT SDN BHD |
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3 July 2023 |
URGENT PRODUCT CORRECTION NOTIFICATION Potential Biased Results using VITROS® Chemistry Products Calibrator Kit 20, Lot 2022
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ORTHO-CLINICAL DIAGNOSTICS, INC. IMMUNOCHEMISTRY TRANSPORT PROTEINS |
MDA/FCA/P0421-48211445-2023 |
IVDB45947352518 |
QuidelOrtho (formerly Ortho Clinical Diagnostics) recently became aware that VITROS® Chemistry Products Calibrator Kit 20, Lot 2022 has the potential to cause biased results in the upper end of the reportable range for the assays |
MENG TSE LEEAU MANAGING DIRECTOR T T MEDICAL MANAGEMENT SDN BHD |
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28 April 2023 |
Intra-Aortic Balloon Pump (IABP), Short Battery Run Times - Advisory Notice |
ARROW AUTOCAT 2 WAVE INTRA-AORTIC BALLOON PUMP (IABP) SYSTEM |
MDA/FCA/P0336-38167638-2023 |
GD44414701118 |
Arrow International LLC, a subsidiary of Teleflex Incorporated, has initiated a voluntary Field Safety Corrective Action (FSCA) for the product codes referenced above due to a potential issue with short battery run‐times on the affected intra‐aortic balloon pump (IABP) devices. |
LIM YI HUI REGULATORY AFFAIRS SPECIALIST TELEFLEX MEDICAL SDN.BHD |
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20 June 2023 |
MAQUET CARDIOSAVE IABP |
MDA/FCA/P0402-38953314-2023 |
GC51897893518 |
This is a new recall, separate from the earlier reported recall involving four (4) issues regarding unexpected shutdown and helium leaks. Datascope Corp., a subsidiary of Getinge is initiating a voluntary Medical Device Correction for the Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP), Safety Disks, and PIMs, due to the Safety Disk not meeting a performance requirement that may result in the reduction of Intra-Aortic Balloon catheter (IAB) displacement volume by up to 3.6%. |
TAN AIK CHUNG DIRECTOR VITALTECH SERVICES SDN BHD |
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20 June 2023 |
URGENT FIELD SAFETY NOTICE MEDICAL DEVICE CORRECTION Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP)
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MAQUET CARDIOSAVE IABP |
MDA/FCA/P0403-38501879-2023 |
GC51897893518 |
Issue 1: Should a Power Management Board Charging Path Circuit be damaged; the pump will be unable to charge inserted batteries despite being connected to AC power. Issue 2: An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. |
TAN AIK CHUNG DIRECTOR VITALTECH SERVICES SDN BHD |
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6 July 2023 |
URGENT Field Safety Notice -MEDICAL DEVICE REMOVAL
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INTRA AORTIC BALLOON CATHETER SYSTEM |
MDA/FCA/P0408-87834534-2023 |
GD75469900118 |
There have been Customer reports of the introducer dilator included within Datascope/Getinge IAB insertion kits fracturing at the hub when attempting to remove the introducer dilator from the sheath, leaving the introducer dilator body housed within the sheath. |
TAN AIK CHUNG DIRECTOR VITALTECH SERVICES SDN BHD |
