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FIELD CORRECTIVE ACTION LISTING FOR AUGUST 2024
The list below contains Medical Device’s Field Corrective Action for the month of August 2024. 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 –
- The return of the medical device to the establishment;
- Modification of the medical device;
- Exchange of the medical device;
- Destruction of medical device; or
- 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.
|
No. |
Date of FCA |
Title of FCA |
Affected Medical Device |
MDA Reference Number |
MDA Registration Number |
Local Establishment Contact Detail |
|
1 |
01/08/2024 |
CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT |
MDA/FCA/P0915-78783797-2024 |
GB7561822-102555 |
GE HEALTHCARE SDN. BHD |
|
|
2 |
02/08/2024 |
AZURION 3 |
MDA/FCA/P0916-71598304-2024 |
GC99381544218 |
PHILIPS MALAYSIA SDN BERHAD |
|
|
3 |
02/08/2024 |
AZURION 7 |
MDA/FCA/P0917-27622222-2024 |
GC82521235717 |
PHILIPS MALAYSIA SDN BERHAD |
|
|
4 |
02/08/2024 |
AZURION BIPLANE |
MDA/FCA/P0918-91175358-2024 |
GC59959884718 |
PHILIPS MALAYSIA SDN BERHAD |
|
|
6 |
06/08/2024 |
MiniMed 600 series and 700 series pump systems – Battery status alerts and alarms |
MINIMED 640G SYSTEM AND ACCESSORIES |
MDA/FCA/P0923-78453865-2024 |
GC8430922-106837 |
MEDTRONIC MALAYSIA SDN BHD |
|
7 |
06/08/2024 |
MINIMED 700 INSULIN PUMP AND KIT |
MDA/FCA/P0924-27953816-2024 |
GC8922821-64034 |
MEDTRONIC MALAYSIA SDN BHD |
|
|
8 |
06/08/2024 |
MINIMED 780G SYSTEM AND ACCESSORIES |
MDA/FCA/P0925-21148141-2024 |
GC4190021-62126 |
MEDTRONIC MALAYSIA SDN BHD |
|
|
9 |
08/08/2024 |
All CADD-Solis™ 21-2160-51 Li-ion Rechargeable Battery Packs |
CADD SOLIS AMBULATORYINFUSION PUMP |
MDA/FCA/P0919-71062534-2024 |
GC5586521-80774 |
PRIMED MEDICAL SDN BHD |
|
10 |
08/08/2024 |
Misconnection of Patient Breathing Circuit to ACGO Port Leading to Risk of Excessive Pressure |
AISYS CS2 |
MDA/FCA/P0929-57253413-2024 |
GC59982267817 |
GE HEALTHCARE SDN. BHD |
|
11 |
08/08/2024 |
NASOPHARYNGEAL AIRWAY |
MDA/FCA/P0930-71735662-2024 |
GA592461076618 |
PRIMED MEDICAL SDN BHD |
|
|
12 |
09/08/2024 |
Leaking vials on haematology Quality Controls and Calibrators |
SYSMEX_HAEMATOLOGY_OTHER HAEMATOLOGY TESTS |
MDA/FCA/P0931-89508931-2024 |
IVDB17531114618 |
SYSMEX (MALAYSIA) SDN. BHD. |
|
13 |
12/08/2024 |
BD PHOENIX™ Automated Microbiology System has the potential for misidentifying E. coli |
BD PHOENIX™ AUTOMATED MICROBIOLOGY SYSTEM |
MDA/FCA/P0927-15043141-2024 |
IVDB10660623-151263 |
BECTON DICKINSON SDN BHD |
|
14 |
14/08/2024 |
|
MULTICOMPONENT COLLECTION SYSTEM MCS®+ (DISPOSABLES) |
MDA/FCA/P0933-82077942-2024 |
GC58057467517 |
HAEMONETICS MALAYSIA SDN. BHD. |
|
15 |
16/08/2024 |
Centricity PACS image limit leading to potential partial study acquisition |
CENTRICITY PACS (RA1000) |
MDA/FCA/P0938-37449326-2024 |
GB5191623-131514 |
GE HEALTHCARE SDN. BHD |
|
16 |
19/08/2024 |
FlexArm Longitudinal Motion Issue Longitudinal motorized movement may not perform as intended |
AZURION 7 |
MDA/FCA/P0940-70033550-2024 |
GC82521235717 |
PHILIPS MALAYSIA SDN BERHAD |
|
17 |
19/08/2024 |
ATELLICA® CH MICROALBUMIN_2 (MALB_2) |
MDA/FCA/P0944-29580606-2024 |
IVDB2257286017 |
SIEMENS HEALTHCARE SDN. BHD. |
|
|
18 |
21/08/2024 |
Notification for New FSCA MAQUET CARDIOSAVE Hybrid and MAQUET CARDIOSAVE Rescue |
CARDIOSAVE INTRA-AORTIC BALLOON PUMP |
MDA/FCA/P0941-10653701-2024 |
GC2992923-137663 |
RBD HEALTHCARE SDN BHD |
|
19 |
21/08/2024 |
ATELLICA® CH LACTATE_3 (LAC_3) |
MDA/FCA/P0945-82863533-2024 |
IVDB5904622-106142 |
SIEMENS HEALTHCARE SDN. BHD. |
|
|
20 |
23/08/2024 |
STERRAD™ 100NX Sterilizers and STERRAD NX™ Sterilizers UV lamp power supply |
ASP STERRAD 100NX STERILIZATION SYSTEM |
MDA/FCA/P0946-10620577-2024 |
GC15247682318 |
RAPHA MEDICAL SDN. BHD. |
|
21 |
23/08/2024 |
Potential Cybersecurity Risk for Welch Allyn Configuration Tool |
WELCH ALLYN CONNEX SPOT MONITOR |
MDA/FCA/P0947-18986624-2024 |
GB2941520-49095 |
WELCH ALLYN MALAYSIA SDN BHD |
|
22 |
23/08/2024 |
Potential for Invalid Calibrations with Atellica IM and ADVIA Centaur Systems Rubella IgG Assay |
ATELLICA® IM RUBELLA IGG (RUB G) |
MDA/FCA/P0949-85505471-2024 |
IVDC17674265918 |
SIEMENS HEALTHCARE SDN. BHD. |
|
23 |
23/08/2024 |
|
STEALTHSTATION S8 CRANIAL SYSTEM |
MDA/FCA/P0950-37592428-2024 |
GC7686023-140750 |
MEDTRONIC MALAYSIA SDN BHD |
|
24 |
23/08/2024 |
STEALTHSTATION S8 SPINAL SYSTEM |
MDA/FCA/P0951-94529209-2024 |
GC6531123-143275 |
MEDTRONIC MALAYSIA SDN BHD |
|
|
25 |
23/08/2024 |
STEALTHSTATION S8 ENT SYSTEM |
MDA/FCA/P0952-41767684-2024 |
GC771281137418 |
MEDTRONIC MALAYSIA SDN BHD |
|
|
26 |
23/08/2024 |
STEALTHSTATION FLEXENT SYSTEM |
MDA/FCA/P0953-73897794-2024 |
GC6421521-58428 |
MEDTRONIC MALAYSIA SDN BHD |
|
|
27 |
23/08/2024 |
Potential Cybersecurity Risk for Welch Allyn Configuration Tool |
WELCHALLYN VITAL SIGNS MONITOR 6000 SERIES |
MDA/FCA/P0954-44480929-2024 |
GC668071053318 |
WELCH ALLYN MALAYSIA SDN BHD |
|
28 |
26/08/2024 |
AZURION BIPLANE |
MDA/FCA/P0959-16705469-2024 |
GC59959884718 |
PHILIPS MALAYSIA SDN BERHAD |
|
|
29 |
26/08/2024 |
AZURION 5 |
MDA/FCA/P0957-17492430-2024 |
GC10785320-48186 |
PHILIPS MALAYSIA SDN BERHAD |
|
|
30 |
26/08/2024 |
AZURION 7 |
MDA/FCA/P0958-34030414-2024 |
GC82521235717 |
PHILIPS MALAYSIA SDN BERHAD |
|
|
31 |
28/08/2024 |
CN-COAGWASHER Remained Stability Time Error on CN Software Ver.0.23-00 |
Sysmex_Automated Coagulation Analyzer_CN Series |
MDA/FCA/P0942-33890992-2024 |
IVDC6362721-66356 |
SYSMEX (MALAYSIA) SDN. BHD. |
