FIELD CORRECTIVE ACTION LISTING FOR JULY 2025
The list below contains Medical Device’s Field Corrective Action for the month of July 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.
MEDICAL DEVICE FIELD CORRECTIVE ACTION LISTING JULY 2025
|
No. |
Date Received |
Title of FCA |
Affected Medical Device |
MDA Reference Number |
MDA Registration Number |
Local Establishment Contact Detail |
|
1. |
05/07/2025 |
Hypromellose 0.3% W/V Eye Drops Without Preservative (AIN Opththal Mellose) With Safety and Performance Issue |
HYPROMELLOSE 0.3% W/V EYE DROPS WITHOUT PRESERVATIVE |
GB5836723-114988 |
AIN MEDICARE SDN BHD |
|
|
2. |
03/07/2025 |
ABL90 FLEX and ABL90 FLEX PLUS - Analyzer May Cease to Perform Calibrations Upon Restart |
ABL90 FLEX |
IVDC5590952317 |
RADIOMETER MALAYSIA SDN. BHD |
|
|
3. |
08/07/2025 |
INNOVANCE VWF Ac - Elevated Control and Patient Sample Results |
INNOVANCE VWF AC |
IVDC4353824-168298 |
SYSMEX (MALAYSIA) SDN. BHD. |
|
|
4. |
01/07/2025 |
Automated Impella Controller (Aic) Could Not Detect Pumps |
IMPELLA CP® WITH SMARTASSIST® SET |
GD9474523-140294 |
DCH AURIGA (M) SDN BHD |
|
|
5. |
02/07/2025 |
PFA_4010746 - Tourniquet Cuffs 5921-024-235, 5921-018-135, 5921-018-235 - Loss of Pressure - Detached Flange |
STRYKER SMARTPUMP TOURNIQUE SYSTEM |
GB83002796818 |
STRYKER CORPORATION (MALAYSIA) SDN. BHD. |
|
|
6. |
03/07/2025 |
GE Healthcare – Certain MR Systems – Functional Check of MR Table Caster Locks During Planned Maintenance |
OPTIMA MR450W 1.5T |
GB17854320917 |
GE HEALTHCARE SDN. BHD |
|
|
7. |
03/07/2025 |
GE Healthcare – Certain MR Systems – Functional Check of MR Table Caster Locks During Planned Maintenance |
SIGNA PREMIER |
GB4732721-52963 |
GE HEALTHCARE SDN. BHD |
|
|
8. |
04/07/2025 |
False Resistant Colistin (Cs02n) In VITEK® 2 AST GN Cards |
VITEK® 2 AST-N439 |
IVDB6843824-161221 |
BIOMERIEUX MALAYSIA SDN BHD |
|
|
9. |
04/07/2025 |
False Resistant Colistin (Cs02n) In VITEK® 2 AST GN Cards For Acinetobacter Baumannii Complex and Pseudomonas Aeruginosa |
VITEK® 2 ANTIMICROBIAL SUSCEPTIBILITY TESTING (AST) CARD |
IVDB7784623-128365 |
BIOMERIEUX MALAYSIA SDN BHD |
|
|
10. |
07/07/2025 |
2024-PD-MR-023 Philips MR Systems Gradient Coil Component Failures May Act as A Heat Source with Potential to Produce Smoke and/or Fire. |
INGENIA 1.5T, INGENIA 3.0T |
GB63162332517 |
PHILIPS MALAYSIA SDN BERHAD |
|
|
11. |
07/07/2025 |
INGENIA AMBITION |
GB2356219-30045 |
PHILIPS MALAYSIA SDN BERHAD |
||
|
12. |
07/07/2025 |
INGENIA ELITION |
GB179941251719 |
PHILIPS MALAYSIA SDN BERHAD |
||
|
13. |
07/07/2025 |
2024-PD-MR-023 Philips MR Systems Gradient Coil Component Failures May Act as a Heat Source with Potential to Produce Smoke and/or Fire. |
MR 5300 |
GB2458922-104130 |
PHILIPS MALAYSIA SDN BERHAD |
|
|
14. |
09/07/2025 |
FA-001384 UIBC OSR61205 Is Not Meeting Interference Claims for Haemoglobin Interference Serum Application. |
ANAEMIA |
IVDB10309423-125411 |
BECKMAN COULTER MALAYSIA SDN. BHD. |
|
|
15. |
08/07/2025 |
FA-25050- BEC Identified an Issue on Unicel Dxi 800 Systems With Linear Slide PNP Gantries Running Software Versions 5.7 and Up. |
UniCel DxI Access Immunoassay Systems |
IVDA9233125-201119 |
BECKMAN COULTER MALAYSIA SDN. BHD. |
|
|
16. |
09/07/2025 |
FA-25046-Multiple Customers Reported Receiving High Patient Results When Using Access Thyroglobulin Reagent Pack Lot 439163. |
ANAEMIA |
IVDB10309423-125411 |
BECKMAN COULTER MALAYSIA SDN. BHD. |
|
|
17. |
14/07/2025 |
(FCA2417) Air Dryer Drain Trap Nut Rust Prevention Measures Due to Different Parts |
Automated Immunoassay System HISCL 5000 & HISCL 800 |
IVDA6474623-114157 |
SYSMEX (MALAYSIA) SDN. BHD. |
|
|
18. |
09/07/2025 |
FA-25046-Multiple Customers Reported Receiving High Patient Results When Using Access Thyroglobulin Reagent Pack Lot 439163. |
THYROID FUNCTION MARKERS |
IVDB7247723-115154 |
BECKMAN COULTER MALAYSIA SDN. BHD. |
|
|
19. |
09/07/2025 |
035 FSCA POC 25-014 Epoc BGEM BUN Test Card |Epoc Negative Sodium Bias on Multiple Test Card Lots |
EPOC BLOOD ANALYSIS SYSTEM |
IVDC7557621-75750 |
SIEMENS HEALTHCARE SDN. BHD. |
|
|
20. |
14/07/2025 |
PRODUCT NOTIFICATION: BDB-25-5314-FA BD FACS™ 7-Color Setup Beads BD Has Identified Errors in The Spectral Overlap Factors (SOF) Table Provided for Specific Lots of BD FACS™ 7-Color Setup Beads as Listed in The Table Above. This Issue May Affect the Accuracy of Flow Cytometry Data Due to Incorrect Flow Cytometry Setup Compensation Values for Multicolor Reagents for Which Proper Fluorescence Compensation Is Required Prior To Analyzing Samples |
FLOW CYTOMETRY SYSTEM |
IVDA46167248618 |
BECTON DICKINSON SDN BHD |
|
|
21. |
14/07/2025 |
(FCA2417) Air dryer drain trap nut rust prevention measures due to different parts |
Sysmex_Automated Coagulation Analyzer_CN Series |
IVDC6362721-66356 |
SYSMEX (MALAYSIA) SDN. BHD. |
|
|
22. |
17/07/2025 |
Securement flange of Bivona® Aire-Cuf®, TTS™, Uncuffed, Mid-Range Neonatal/Pediatric Tracheostomy Tube(s) and Bivona Aire-Cuf®, TTS™, Cuffless FlexTend™, TTS™ FlexTend™ Adult Tracheostomy Tube(s) manufacturing defect |
BIVONA SILICONE TRACHEOSTOMY TUBE |
GC8583224-187732 |
PRIMED MEDICAL SDN BHD |
|
|
23. |
24/07/2025 |
Olympus to Provide Update on ESG-410 Board MoBiNE |
ELECTROSURGICAL GENERATOR ESG-410 |
GC5599621-63426 |
OLYMPUS (MALAYSIA) SDN. BHD. |
|
|
24. |
24/07/2025 |
Shimadzu Radspeed Pro ceiling tube support - CH200/CH200M. Potential shaft failure on ceiling tube support may lead to support detachment, corrective measure required. |
RADSPEED PRO |
GC4930621-68598 |
SHIMADZU MALAYSIA SDN BHD |
|
|
25. |
24/07/2025 |
97391810-FA RELIANCE ePTFE Gradual Rise in Shock Impedance Advisory Field Action |
RELIANCE 4-FRONT LEADS AND ACCESSORIES |
GD6820621-78032 |
BOSTON SCIENTIFIC (MALAYSIA) SDN BHD |
|
|
26. |
29/07/2025 |
97423085-FA Watchman Air Embolism |
WATCHMAN™ TRUSEAL™ ACCESS SYSTEM |
GD8611519-30092 |
BOSTON SCIENTIFIC (MALAYSIA) SDN BHD |
|
|
27. |
31/07/2025 |
Voluntary FSCA Fortress Introducer Sheath System - We have identified that some units within Lot Number 800989 of the Fortress Introducer System, 6F, Straight 45cm, may have been packaged with an incorrect pouch label. |
FORTRESS INTRODUCER SHEATH SYSTEM, 5F AND 6F |
GB54392600818 |
BIOTRONIK MEDICAL DEVICES (MALAYSIA) SDN. BHD |
* The information contained in the Medical Device Authority Field Corrective Action database is released under Regulation 7(8) and Regulation 8 (5) of Malaysia’s Medical Device Regulations 2019.
