MEDICAL DEVICE FIELD CORRECTIVE ACTION LISTING OCTOBER 2025
The list below contains Medical Device’s Field Corrective Action for the month of October 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 OCTOBER 2025
|
No. |
Date Received |
Title of FCA |
Affected Medical Device |
MDA Reference Number |
MDA Registration Number |
Local Establishment Contact Detail |
|
1. |
01/10/2025 |
LOGIQ P9, P10 R4.5.7 Enhancement of UGAP Measurement Result LOGIQ P SERIES (LOGIQ P8, LOGIQ P9, LOGIQ P10) (GB4889221-73580) |
LOGIQ P SERIES (LOGIQ P8, LOGIQ P9, LOGIQ P10) |
GB4889221-73580 |
GE HEALTHCARE SDN. BHD |
|
|
2. |
01/10/2025 |
LOGIQ P9, P10 R4.5.7 Enhancement of UGAP Measurement Result LOGIQ P SERIES (GB6568122-103525) |
LOGIQ P SERIES |
GB6568122-103525 |
GE HEALTHCARE SDN. BHD |
|
|
3. |
07/10/2025 |
FA-25071- Beckman Coulter has confirmed a software anomaly on DxI 9000 analyzers that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". |
ACCESS PROGESTERONE II |
IVDB9522424-187370 |
BECKMAN COULTER MALAYSIA SDN. BHD. |
|
|
4. |
07/10/2025 |
FA-25071- Beckman Coulter has confirmed a software anomaly on DxC 500i analyzers that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". |
DxC 500i AU Chemistry Module |
IVDA8913224-171351 |
BECKMAN COULTER MALAYSIA SDN. BHD. |
|
|
5. |
03/10/2025 |
2024-IGT-PUN-004 Zenition 50 Potential loss of imaging functionality and/or poor image quality |
ZENITION 50 |
GC2933619-31252 |
PHILIPS MALAYSIA SDN BERHAD |
|
|
6. |
07/10/2025 |
IDS-25-5176- EXP Product Cybersecurity Matter |
BD PHOENIX™ AUTOMATED MICROBIOLOGY SYSTEM |
IVDB10660623-151263 |
BECTON DICKINSON SDN BHD |
|
|
7. |
14/10/2025 |
Olympus to Reinforce the IFU |
SHOCKPULSE-SE LITHOTRIPSY SYSTEM |
GC92154340917 |
OLYMPUS (MALAYSIA) SDN. BHD. |
|
|
8. |
08/10/2025 |
FA-24068 - Supplier manufacturing nonconformance in PnP collet covers (C20585) from a Dec 2023-Jan 2024 batch causing overly thick flags to rub and damage Z-axis sensors (C20586). |
UniCel DxI Access Immunoassay Systems |
IVDA9233125-201119 |
BECKMAN COULTER MALAYSIA SDN. BHD. |
|
|
9. |
09/10/2025 |
Potential mycobacterial contamination on Heater Unit HU35 |
HEATER UNIT HU35 |
GC6292720-45160 |
RBD HEALTHCARE SDN BHD |
|
|
10. |
13/10/2025 |
Olympus to Provide Online Training Materials on Reprocessing for TJF Duodenoscopes |
EVIS EXERA III DUODENOVIDEOSCOPE TJF-Q190V |
GB4632321-70352 |
OLYMPUS (MALAYSIA) SDN. BHD. |
|
|
11. |
15/10/2025 |
CentriMag Pump OOS not fitting in the CentriMag Motor |
CENTRIMAG AND PEDIVAS EXTRACORPOREAL BLOOD PUMPING SYSTEM |
GC37805334117 |
ABBOTT MEDICAL (MALAYSIA) SDN. BHD. |
|
|
12. |
15/10/2025 |
HeartMate Controller Backup Battery Fault |
HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM |
GD4151721-74880 |
ABBOTT MEDICAL (MALAYSIA) SDN. BHD. |
|
|
13. |
22/10/2025 |
AccuScreen DPOAE Probe - inducing technical distortions on high sound levels |
MADSEN ACCUSCREEN |
GB3401824-162662 |
ACCESS 2 HEALTHCARE SDN BHD |
|
|
14. |
22/10/2025 |
Automated Impella Controller (AIC) Cybersecurity Notification |
IMPELLA CP® WITH SMARTASSIST® SET |
GD9474523-140294 |
DCH AURIGA (M) SDN BHD |
|
|
15. |
17/10/2025 |
PCS/MS – Potential FLEX-3S2P battery functional failures PORTRAIT VSM VITAL SIGNS MONITOR (GC7676824-159439) |
PORTRAIT VSM VITAL SIGNS MONITOR |
GC7676824-159439 |
GE HEALTHCARE SDN. BHD |
|
|
16. |
17/10/2025 |
PCS/MS – Potential FLEX-3S2P battery functional failures CARESCAPE ONE (GC5319024-173964) |
CARESCAPE ONE |
GC5319024-173964 |
GE HEALTHCARE SDN. BHD |
|
|
17. |
17/10/2025 |
PCS/MS – Potential FLEX-3S2P battery functional failures B105P/B105M/B125P/B125M/B155M PATIENT MONITOR ( GC5462723-144051) |
B105P/B105M/B125P/B125M/B155M PATIENT MONITOR |
GC3218021-63208 |
GE HEALTHCARE SDN. BHD |
|
|
18. |
17/10/2025 |
PCS/MS – Potential FLEX-3S2P battery functional failures CARESCAPE MONITOR B450 (GC52869540718) |
CARESCAPE MONITOR B450 |
GC52869540718 |
GE HEALTHCARE SDN. BHD |
|
|
19. |
17/10/2025 |
PCS/MS – Potential FLEX-3S2P battery functional failures CARESCAPE B850 B650 B450 (GC7153322-104146 |
CARESCAPE B850 B650 B450 |
GC7153322-104146 |
GE HEALTHCARE SDN. BHD |
|
|
20. |
21/10/2025 |
FA-25054 Customer complaints were received for multiple Bicarbonate reagent lots associated with false high patient results for Bicarbonate. The high results are due to elevated levels of LDH in the patient samples tested. The current Bicarbonate product IFU’s do not advise of LDH interference with this assay. |
BECKMAN COULTER ELECTROLYTE REAGENTS |
IVDB2268977017 |
BECKMAN COULTER MALAYSIA SDN. BHD. |
|
|
21. |
22/10/2025 |
Liquid leaking from the “Valve _Assy NO.339” built in CN |
Sysmex_Automated Coagulation Analyzer_CN Series |
MDA/FCA/P1451-18248256-2025 |
IVDC6362721-66356 |
SYSMEX (MALAYSIA) SDN. BHD |
|
22. |
22/10/2025 |
FA1524 CareLink Clinic Dashboard Display Correction |
GUARDIAN CONNECT SYSTEM AND ACCESSORIES |
GB8317423-114689 |
MEDTRONIC MALAYSIA SDN BHD |
|
|
23. |
23/10/2025 |
Field Safety Notice on accuracy of Triglyceride, Total Cholesterol and Low-Density Lipoprotein Cholesterol analytes when using the Afinion™ Lipid Panel |
AFINION LIPID PANEL |
IVDB74056332218 |
ABBOTT DIAGNOSTICS HEALTH SDN BHD |
|
|
24. |
23/10/2025 |
003 FSCA AIMC 25-06 Follow Up Atellica IM ADVIA Centaur Homocysteine Calibrator | Atellica IM and ADVIA Centaur Homocysteine Calibrator Instability |
ATELLICA® IM HOMOCYSTEINE (HCY) |
IVDB59216279518 |
SIEMENS HEALTHCARE SDN. BHD. |
|
|
25. |
27/10/2025 |
2025-PD-CTAMI-107 - Philips CT Systems - Potential for System Shutdown and Expelled Parts |
INCISIVE CT |
GC74519972618 |
PHILIPS MALAYSIA SDN BERHAD |
|
|
26. |
28/10/2025 |
Field action for InteliQ Immunology Control to revise the in-use stability claim for anti-cyclic Citrullinated Peptide (anti-CCP). |
INTELIQ IMMUNOLOGY CONTROL |
IVDB9987521-63532 |
CHEMOPHARM SDN BHD |
|
|
27. |
29/10/2025 |
EA 9180 Na discrepant results |
REFERENCE ELECTRODE |
IVDB7921024-186374 |
ROCHE DIAGNOSTICS (M) SDN. BHD |
|
|
28. |
29/10/2025 |
A problem related to the device failing to start mechanical CPR after the software update to version 1.1.3 occurred |
EASY PULSE - MECHANICAL CPR |
GC8466522-101961 |
SCHILLER ASIA PACIFIC SDN. BHD |
|
|
29. |
29/10/2025 |
Hoses of the Catheter Mounts may tear during use and lead to leakages (ErgoStars with smoothbore hoses). |
DRAEGER SAVINA FAMILY |
GC84895244017 |
DRAEGER MALAYSIA SDN BHD |
|
|
30. |
30/10/2025 |
Clear-Therm Mini Paediatric HMEF housings separate when a force is applied |
BREATHING FILTERS, HMES AND HMEFS |
GB890231283619 |
INTERSURGICAL SDN BHD |
|
|
31. |
30/10/2025 |
FA1511 Rev A_Potential for Suspension of Dynamic Sensing Algorithm Aurora EV-ICD (DVEA3E4) |
AURORA EV-ICD™ SYSTEM |
GD2666524-159481 |
MEDTRONIC 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.
