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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 |
pdf MiniMed 600 series and 700 series pump systems – Battery status alerts and alarms (384 KB) |
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 |
pdf All CADD-Solis™ 21-2160-51 Li-ion Rechargeable Battery Packs (288 KB) |
CADD SOLIS AMBULATORYINFUSION PUMP |
MDA/FCA/P0919-71062534-2024 |
GC5586521-80774 |
PRIMED MEDICAL SDN BHD |
|
10 |
08/08/2024 |
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 |
pdf Leaking vials on haematology Quality Controls and Calibrators (372 KB) |
SYSMEX_HAEMATOLOGY_OTHER HAEMATOLOGY TESTS |
MDA/FCA/P0931-89508931-2024 |
IVDB17531114618 |
SYSMEX (MALAYSIA) SDN. BHD. |
|
13 |
12/08/2024 |
pdf BD PHOENIX™ Automated Microbiology System has the potential for misidentifying E. coli (728 KB) |
BD PHOENIX™ AUTOMATED MICROBIOLOGY SYSTEM |
MDA/FCA/P0927-15043141-2024 |
IVDB10660623-151263 |
BECTON DICKINSON SDN BHD |
|
14 |
14/08/2024 |
pdf (Product Item: 997CF-E) (123 KB)
|
MULTICOMPONENT COLLECTION SYSTEM MCS®+ (DISPOSABLES) |
MDA/FCA/P0933-82077942-2024 |
GC58057467517 |
HAEMONETICS MALAYSIA SDN. BHD. |
|
15 |
16/08/2024 |
pdf Centricity PACS image limit leading to potential partial study acquisition (366 KB) |
CENTRICITY PACS (RA1000) |
MDA/FCA/P0938-37449326-2024 |
GB5191623-131514 |
GE HEALTHCARE SDN. BHD |
|
16 |
19/08/2024 |
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 |
pdf Notification for New FSCA MAQUET CARDIOSAVE Hybrid and MAQUET CARDIOSAVE Rescue (347 KB) |
CARDIOSAVE INTRA-AORTIC BALLOON PUMP |
MDA/FCA/P0941-10653701-2024 |
GC2992923-137663 |
RBD HEALTHCARE SDN BHD |
|
19 |
21/08/2024 |
pdf Atellica CH Lactate_3 (Lac_3) Pack Calibration Instability (243 KB) |
ATELLICA® CH LACTATE_3 (LAC_3) |
MDA/FCA/P0945-82863533-2024 |
IVDB5904622-106142 |
SIEMENS HEALTHCARE SDN. BHD. |
|
20 |
23/08/2024 |
pdf STERRAD™ 100NX Sterilizers and STERRAD NX™ Sterilizers UV lamp power supply (454 KB) |
ASP STERRAD 100NX STERILIZATION SYSTEM |
MDA/FCA/P0946-10620577-2024 |
GC15247682318 |
RAPHA MEDICAL SDN. BHD. |
|
21 |
23/08/2024 |
pdf Potential Cybersecurity Risk for Welch Allyn Configuration Tool (169 KB) |
WELCH ALLYN CONNEX SPOT MONITOR |
MDA/FCA/P0947-18986624-2024 |
GB2941520-49095 |
WELCH ALLYN MALAYSIA SDN BHD |
|
22 |
23/08/2024 |
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 |
pdf Potential Cybersecurity Risk for Welch Allyn Configuration Tool (169 KB) |
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 |
pdf CN-COAGWASHER Remained Stability Time Error on CN Software Ver.0.23-00 (529 KB) |
Sysmex_Automated Coagulation Analyzer_CN Series |
MDA/FCA/P0942-33890992-2024 |
IVDC6362721-66356 |
SYSMEX (MALAYSIA) SDN. BHD. |
