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FIELD CORRECTIVE ACTION LISTING FOR JANUARY 2025
The list below contains Medical Device’s Field Corrective Action for the month of January 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 |
02/01/2025 |
LIAISON® ANTI-HBC |
MDA/FCA/P1130-14104111-2025 |
IVDD2249122-109829 |
DIAGNOSTICARE SDN BHD |
|
|
2 |
02/01/2025 |
ACCESS PCT |
MDA/FCA/P1134-18429856-2025 |
IVDC6748024-166642 |
BECKMAN COULTER MALAYSIA SDN. BHD. |
|
|
3 |
03/01/2025 |
Pitch Cable Failures on da Vinci X and Xi Tenaculum Forceps and Small GraptorTM |
DA VINCI XI SURGICAL SYSTEM, ENDOSCOPIC INSTRUMENT CONTROL SYSTEM, MODEL IS4000 |
MDA/FCA/P1119-22749179-2024 |
GC3810021-64842 |
DTG MEDICAL SDN BHD |
|
4 |
03/01/2025 |
Grip Cable Failures on da Vinci X and Xi Reusable Instruments with Jaws |
DA VINCI XI SURGICAL SYSTEM, ENDOSCOPIC INSTRUMENT CONTROL SYSTEM, MODEL IS4000 |
MDA/FCA/P1117-41768852-2024 |
GC3810021-64842 |
DTG MEDICAL SDN BHD |
|
5 |
09/01/2025 |
HEARTWARE® VENTRICULAR ASSIST DEVICE (HVAD®) ACCESSORIES SYSTEM |
MDA/FCA/P1136-75285346-2025 |
GD2555223-122718 |
MEDTRONIC MALAYSIA SDN BHD |
|
|
6 |
13/01/2025 |
Updating product-specific Instructions for Use (IFU) for Haemostatic forceps |
SURGICAL FORCEPS |
MDA/FCA/P1137-62347179-2025 |
GA826961015518 |
B. BRAUN MEDICAL INDUSTRIES SDN. BHD. |
|
7 |
14/01/2025 |
ALINITY M SYSTEM |
MDA/FCA/P1138-58042219-2025 |
IVDB7120020-41682 |
ABBOTT LABORATORIES (MALAYSIA) SDN. BHD. |
|
|
8 |
15/01/2025 |
Tec 6 Plus vaporizers can deliver reduced concentration of volatile anesthetic agent |
TEC 6 PLUS |
MDA/FCA/P1139-89761501-2025 |
GC9756223-128902 |
GE HEALTHCARE SDN. BHD |
|
9 |
16/01/2025 |
|
AZURION 3 |
MDA/FCA/P1140-89562790-2025 |
GC99381544218 |
PHILIPS MALAYSIA SDN BERHAD |
|
10 |
16/01/2025 |
AZURION 5 |
MDA/FCA/P1141-96278555-2025 |
GC10785320-48186 |
PHILIPS MALAYSIA SDN BERHAD |
|
|
11 |
16/01/2025 |
AZURION 7 |
MDA/FCA/P1142-86242538-2025 |
|
PHILIPS MALAYSIA SDN BERHAD |
|
|
12 |
16/01/2025 |
AZURION BIPLANE |
MDA/FCA/P1143-51459141-2025 |
GC59959884718 |
PHILIPS MALAYSIA SDN BERHAD |
|
|
13 |
16/01/2025 |
AZURION 3 |
MDA/FCA/P1144-22082165-2025 |
GC99381544218 |
PHILIPS MALAYSIA SDN BERHAD |
|
|
14 |
16/01/2025 |
AZURION 5 |
MDA/FCA/P1145-93022840-2025 |
GC10785320-48186 |
PHILIPS MALAYSIA SDN BERHAD |
|
|
15 |
16/01/2025 |
AZURION 7 |
MDA/FCA/P1147-40137943-2025 |
|
PHILIPS MALAYSIA SDN BERHAD |
|
|
16 |
16/01/2025 |
AZURION BIPLANE |
MDA/FCA/P1148-34304365-2025 |
GC59959884718 |
PHILIPS MALAYSIA SDN BERHAD |
|
|
17 |
18/01/2025 |
GUIDE SHEATH KIT |
MDA/FCA/P1150-82029198-2025 |
GB61352419917 |
OLYMPUS (MALAYSIA) SDN. BHD. |
|
|
18 |
20/01/2025 |
VITROS IMMUNODIAGNOSTIC PRODUCTS FERTILITY & PREGNANCY HORMONES & PROTEINS |
MDA/FCA/P1155-80197836-2025 |
IVDB7258323-129195 |
T T MEDICAL MANAGEMENT SDN BHD |
