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FIELD CORRECTIVE ACTION LISTING FOR MARCH 2025
The list below contains Medical Device’s Field Corrective Action for the month of March 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 |
Establishment Details |
|
1. |
04/03/2025 |
CENTRICITY UNIVERSAL VIEWER |
MDA/FCA/P1205-78828863-2025 |
GB6437620-46699 |
GE HEALTHCARE SDN. BHD |
|
|
2. |
07/03/2025 |
FA-25022- DxC 500i Clinical Analyzer- Beckman Coulter has determined that the system cannot recalculate a calculated result when results are rerun within the calculated test |
DxC 500i AU Chemistry Module |
MDA/FCA/P1209-84718400-2025 |
IVDA8913224-171351 |
BECKMAN COULTER MALAYSIA SDN. BHD. |
|
3. |
11/03/2025 |
ALINITY M SYSTEM |
MDA/FCA/P1217-81246151-2025 |
IVDB7120020-41682 |
ABBOTT LABORATORIES (MALAYSIA) SDN. BHD. |
|
|
4. |
11/03/2025 |
NIM VITAL SYSTEM |
MDA/FCA/P1218-98649608-2025 |
GB4580925-195936 |
MEDTRONIC MALAYSIA SDN BHD |
|
|
5. |
12/03/2025 |
UPPER ARM BLOOD PRESSURE MONITOR |
MDA/FCA/P1215-22764825-2025 |
GB10141423-121141 |
REVO HEALTHCARE SDN BHD |
|
|
6. |
12/03/2025 |
PHADIA AB IMMUNOCAP™ SPECIFIC IGE |
MDA/FCA/P1220-77969806-2025 |
IVDB2215723-122106 |
BIOMARKETING SERVICES (M) SDN BHD |
|
|
7. |
12/03/2025 |
ENDOSCOPIC VESSEL HARVESTING SYSTEM |
MDA/FCA/P1221-70903560-2025 |
GC68111180517 |
RBD HEALTHCARE SDN BHD |
|
|
8. |
13/03/2025 |
The installation instructions for Intermediate Ceiling Construction (Article No. 89-960-12-04), part of the operating theatre lighting system, contain incorrect tightening torques, though the component itself has no clinical function. |
OPERATING LIGHT |
MDA/FCA/P1219-77992789-2025 |
GMD96238811718A |
KLS MARTIN SE ASIA SDN BHD |
|
9. |
13/03/2025 |
ENDOSCOPIC VESSEL HARVESTING SYSTEM |
MDA/FCA/P1224-89394131-2025 |
GC68111180517 |
RBD HEALTHCARE SDN BHD |
|
|
10. |
13/03/2025 |
Welch Allyn Blood Pressure Gauges |
MDA/FCA/P1225-19484240-2025 |
GA7214422-88069 |
WELCH ALLYN MALAYSIA SDN BHD |
|
|
11. |
13/03/2025 |
Welch Allyn 767 Blood Pressure Gauges |
MDA/FCA/P1226-51944182-2025 |
GA2325622-90637 |
||
|
12. |
14/03/2025 |
ATELLICA® CH REVISED C‑REACTIVE PROTEIN (RCRP) |
MDA/FCA/P1228-57747534-2025 |
IVDB10942623-142160 |
SIEMENS HEALTHCARE SDN. BHD. |
|
|
13. |
17/03/2025 |
ABL90 FLEX analyzer unexpected “freeze” and restart |
ABL90 FLEX |
MDA/FCA/P1214-41883730-2025 |
IVDC5590952317 |
RADIOMETER MALAYSIA SDN. BHD. |
|
14. |
17/03/2025 |
NOVALUNG KITS |
MDA/FCA/P1227-56476376-2025 |
GD7111223-118844 |
MEGSHER MEDIC (M) SDN BHD |
|
|
15. |
19/03/2025 |
CELL-DYN RUBY |
MDA/FCA/P1230-86263341-2025 |
IVDB9465823-115114 |
ABBOTT LABORATORIES (MALAYSIA) SDN. BHD. |
|
|
16. |
19/03/2025 |
DxC 500 AU Clinical Chemistry Analyzer |
MDA/FCA/P1231-72045130-2025 |
IVDA3952124-168118 |
BECKMAN COULTER MALAYSIA SDN. BHD. |
|
|
17. |
19/03/2025 |
DxC 500i AU Chemistry Module |
MDA/FCA/P1232-91158167-2025 |
IVDA8913224-171351 |
||
|
18. |
19/03/2025 |
DxC 500i AU Chemistry Module |
MDA/FCA/P1232-71645655-2025 |
IVDA8913224-171351 |
||
|
19. |
20/03/2025 |
VENUE GO ULTRASOUND SYSTEM |
MDA/FCA/P1235-72426775-2025 |
GB120001319219 |
GE HEALTHCARE SDN. BHD |
|
|
20. |
21/03/2025 |
CENTRICITY HIGH ACUITY ANESTHESIA |
MDA/FCA/P1241-76380635-2025 |
GMD29146275517A |
||
|
21. |
21/03/2025 |
ACCESS UNCONJUGATED ESTRIOL |
MDA/FCA/P1242-37020681-2025 |
IVDB2555024-162080 |
BECKMAN COULTER MALAYSIA SDN. BHD. |
|
|
22. |
24/03/2025 |
SYNGO.VIA VB30 |
MDA/FCA/P1239-63380128-2025 |
GB120001319219 |
SIEMENS HEALTHCARE SDN. BHD. |
|
|
23. |
24/03/2025 |
ALINITY M SYSTEM |
MDA/FCA/P1243-70007271-2025 |
IVDB7120020-41682 |
ABBOTT LABORATORIES (MALAYSIA) SDN. BHD. |
|
|
24. |
25/03/2025 |
EPOC BLOOD ANALYSIS SYSTEM |
MDA/FCA/P1244-53368799-2025 |
IVDC7557621-75750 |
SIEMENS HEALTHCARE SDN. BHD |
|
|
25. |
25/03/2025 |
ATELLICA® CH REVISED C‑REACTIVE PROTEIN (RCRP) |
MDA/FCA/P1245-61271022-2025 |
IVDB10942623-142160 |
||
|
26. |
26/03/2025 |
EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM |
MDA/FCA/P1246-84903910-2025 |
GC2869522-88521 |
MEDTRONIC MALAYSIA SDN BHD |
