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FIELD CORRECTIVE ACTION LISTING FOR FEBRUARY 2025
The list below contains Medical Device’s Field Corrective Action for the month of February 2025. 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 Received |
Title of FCA |
Affected Medical Device |
MDA Reference Number |
MDA Registration Number |
Local Establishment Contact Detail |
|
1. |
03/02/2025 |
FA1446 MiniMed and Paradigm Pump Delivery Volume Accuracy (MiniMed 780G System and Accessories) |
MINIMED 780G SYSTEM AND ACCESSORIES |
MDA/FCA/P1168-72944848-2025 |
GC4190021-62126 |
MEDTRONIC MALAYSIA SDN BHD |
|
2. |
04/02/2025 |
PIPELINE VANTAGE EMBOLIZATION DEVICE WITH SHIELD TECHNOLOGY |
MDA/FCA/P1172-14392084-2025 |
GD8603721-68288 |
MEDTRONIC MALAYSIA SDN BHD |
|
|
3. |
04/02/2025 |
PIPELINE VANTAGE EMBOLIZATION DEVICE WITH SHIELD TECHNOLOGY |
MDA/FCA/P1173-85796139-2025 |
GD8603721-68288 |
MEDTRONIC MALAYSIA SDN BHD |
|
|
4. |
05/02/2025 |
Hamilton-C2/C3 devices for long-term neonatal ventilation switch to "Ambient State" after 91 days. |
MEDICAL VENTILATOR |
MDA/FCA/P1174-80588865-2025 |
GC25545945118 |
STAR MEDIK SDN BHD |
|
5. |
06/02/2025 |
FIELD CORRECTIVE ACTION, FCA-MUC-2024-001, FORUM 4.4 DICOM Metadata not updated |
FORUM |
MDA/FCA/P1175-99051464-2025 |
GB7833715916 |
CARL ZEISS SDN BHD |
|
6. |
06/02/2025 |
ACCESS ULTRASENSITIVE HGH |
MDA/FCA/P1176-28009453-2025 |
IVDB10306623-125414 |
BECKMAN COULTER MALAYSIA SDN. BHD. |
|
|
7. |
06/02/2025 |
RHEUMATOID INFLAMMATORY DISEASE MARKERS |
MDA/FCA/P1177-39096301-2025 |
IVDB8171123-127940 |
BECKMAN COULTER MALAYSIA SDN. BHD. |
|
|
8. |
12/02/2025 |
Getinge Flow-I Sevoflurane Vaporizers: Additional affected units were found. |
GETINGE FLOW-I ANESTHESIA SYSTEM |
MDA/FCA/P1179-91268165-2025 |
GC25644700318 |
IDS MEDICAL SYSTEMS (M) SDN BHD |
|
9. |
12/02/2025 |
ACROBAT-I VACUUM POSITIONER SYSTEM |
MDA/FCA/P1181-78391890-2025 |
GB3824623-138876 |
RBD HEALTHCARE SDN BHD |
|
|
10. |
12/02/2025 |
Sevoflurane vaporizers: Additional information for all Getinge/Maquet sevoflurane vaporizers |
GETINGE FLOW-I ANESTHESIA SYSTEM |
MDA/FCA/P1184-64669568-2025 |
GC25644700318 |
IDS MEDICAL SYSTEMS (M) SDN BHD |
|
11. |
12/02/2025 |
GETINGE FLOW-I ANESTHESIA SYSTEM |
MDA/FCA/P1185-46407335-2025 |
GC25644700318 |
IDS MEDICAL SYSTEMS (M) SDN BHD |
|
|
12. |
14/02/2025 |
Dade Actin FS Activated PTT Reagent - Control recovery issues with Dade Ci-Trol 2 and Dade Ci-Trol 3 |
DADE ACTIN FS ACTIVATED PTT REAGENT |
MDA/FCA/P1186-26399040-2025 |
IVDC695822916 |
SYSMEX (MALAYSIA) SDN. BHD |
|
13. |
14/02/2025 |
URGENT MEDICAL DEVICE CORRECTION Level 1® H-2 Pressure Chamber Door and Latch Replacement Kits |
HOTLINE BLOOD AND FLUID WARMER |
MDA/FCA/P1189-64294013-2025 |
GC5311524-185432 |
PRIMED MEDICAL SDN BHD |
|
14. |
14/02/2025 |
BIVONA SILICONE TRACHEOSTOMY TUBE |
MDA/FCA/P1190-94465734-2025 |
GC8583224-187732 |
PRIMED MEDICAL SDN BHD |
|
|
15. |
16/02/2025 |
DxC 500 AU Clinical Chemistry Analyzer |
MDA/FCA/P1191-50540894-2025 |
IVDA3952124-168118 |
BECKMAN COULTER MALAYSIA SDN. BHD. |
|
|
16. |
17/02/2025 |
HYPROMELLOSE 0.3% W/V EYE DROPS WITHOUT PRESERVATIVE |
MDA/FCA/P1163-75202480-2025 |
GB5836723-114988 |
AIN MEDICARE SDN BHD |
|
|
17. |
17/02/2025 |
FA-AM-FEB2025-304: Abbott RealTime HIV-1 assays and the Alinity m HIV-1 assays |
ALINITY M HIV-1 |
MDA/FCA/P1192-40126137-2025 |
IVDD3748420-39113 |
ABBOTT LABORATORIES (MALAYSIA) SDN. BHD. |
|
18. |
17/02/2025 |
FA-AM-FEB2025-304: Abbott RealTime HIV-1 assays and the Alinity m HIV-1 assays (4N6690) |
ABBOTT REALTIME HIV-1 QUALITATIVE |
MDA/FCA/P1193-73964962-2025 |
IVDD8147970817 |
ABBOTT LABORATORIES (MALAYSIA) SDN. BHD. |
|
19. |
17/02/2025 |
FA-AM-FEB2025-304: Abbott RealTime HIV-1 assays and the Alinity m HIV-1 assays (2G3110) |
ABBOTT REALTIME HIV-1 |
MDA/FCA/P1194-58843080-2025 |
IVDC7467793718 |
ABBOTT LABORATORIES (MALAYSIA) SDN. BHD. |
|
20. |
17/02/2025 |
CK-MB |
MDA/FCA/P1195-25032649-2025 |
IVDC6426122-96352 |
BECKMAN COULTER MALAYSIA SDN. BHD. |
|
|
21.. |
17/02/2025 |
Updating product-specific Instructions for Use (IFU) for Sterilization Containers |
INSTRUMENTS / TOOL FOR REPROCESSING OF MEDICAL DEVICES |
MDA/FCA/P1197-84272830-2025 |
GMD42472682018A |
B. BRAUN MEDICAL INDUSTRIES SDN. BHD. |
|
22. |
18/02/2025 |
ACROBAT-I VACUUM STABILIZER SYSTEM |
MDA/FCA/P1182-91407651-2025 |
GB3805023-133245 |
RBD HEALTHCARE SDN BHD |
|
|
23. |
18/02/2025 |
FA1432 Neonate Airway Adapter - Unable to be Disconnected from Endotracheal Tube |
MICROSTREAM ADVANCE FILTER LINE |
MDA/FCA/P1199-93908751-2025 |
GA2701022-95580 |
MEDTRONIC MALAYSIA SDN BHD |
|
24. |
19/02/2025 |
ASSURITY & ASSURITY MRI PACEMAKERS |
MDA/FCA/P1198-55805208-2025 |
GD71875822118 |
ABBOTT MEDICAL (MALAYSIA) SDN. BHD. |
|
|
25. |
20/02/2025 |
Urgent Field Safety Notice (FSN) - Variation in syringe to line connection |
SEDACONDA ACD |
MDA/FCA/P1180-82484419-2025 |
GB9300821-68674 |
INTEGA SDN. BHD. |
