MEDICAL DEVICE FIELD CORRECTIVE ACTION LISTING NOVEMBER 2025
The list below contains Medical Device’s Field Corrective Action for the month of November 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 NOVEMBER 2025
|
No. |
Date Received |
Title of FCA |
Affected Medical Device |
MDA Reference Number |
MDA Registration Number |
Local Establishment Contact Detail |
|
1. |
12/11/2025 |
Design update and user advice on specimen container device. |
SPECIMEN CONTAINER |
GA6143792916 |
MUZAMAL INDUSTRIES SDN BHD |
|
|
2. |
04/11/2025 |
2025-PD-US-004 Philips Ultrasound Lumify Systems Lumify Systems incompatible with iOS 18 device) |
LUMIFY ULTRASOUND SYSTEM |
GB11274413717 |
PHILIPS MALAYSIA SDN BERHAD |
|
|
3. |
04/11/2025 |
2024-IGT-PUN-011 Zenition 10 C-Arc Cable issue potentially leading to loss of imaging functionality |
ZENITION 10 |
GC3311823-138282 |
PHILIPS MALAYSIA SDN BERHAD |
|
|
4. |
06/11/2025 |
Olympus to Reinforce the IFU & To Provide Supplemental Guidance |
SINGLE LIGATION DEVICE_HX-400U-30 |
GB467001260819 |
OLYMPUS (MALAYSIA) SDN. BHD. |
|
|
5. |
06/11/2025 |
Olympus to Reinforce the Endoscope Reprocessors Operation Manual |
ENDOSCOPE REPROCESSOR_OER-AW |
GC2422865416 |
OLYMPUS (MALAYSIA) SDN. BHD. |
|
|
6. |
07/11/2025 |
005 CN ACHC 26-02 Atellica CH Triglycerides_2 (Trig_2) | Atellica CH Triglycerides_2 (Trig_2) Not Meeting Pack and Lot Calibration Interval |
ATELLICA® CH TRIGLYCERIDES_2 (TRIG_2) |
MDA/FCA/P1478-12903351-2025 |
IVDB5423122-84212 |
SIEMENS HEALTHCARE SDN. BHD. |
|
7. |
14/11/2025 |
Kendall SCD™ 700 Sequential Compression System – Event-2025-07350 Kendall SCD™ 700 Sequential Compression System due to potential safety risks when used with non-Original Equipment Manufacturer (non-OEM) power cords. |
KENDALL SCD COMPRESSION SYSTEM AND ACCESSORIES |
GB75980838218 |
INSAN DAMAI SDN BHD |
|
|
8. |
13/11/2025 |
006 CN ACHC 26-01 Atellica CH Gentamicin (Gent) | Atellica CH Gentamicin (Gent) Not Meeting Pack Calibration Interval on the Atellica CI Analyzer (C20585) from a Dec 2023-Jan 2024 batch causing overly thick flags to rub and damage Z-axis sensors (C20586). |
ATELLICA® CH GENTAMICIN (GENT) |
IVDC38639183118 |
SIEMENS HEALTHCARE SDN. BHD. |
|
|
9. |
13/11/2025 |
IDS-25-5412 : BD BACTEC™ MGIT™ 960 PZA Kit |
SUSCEPTIBILITY AND IDENTIFICATION TEST FOR MYCOBACTERIA |
IVDC23724200218 |
BECTON DICKINSON SDN BHD |
|
|
10. |
14/11/2025 |
Technical alarms appearing randomly during use. |
DEFIGARD TOUCH 7 |
GC9551022-105940 |
SCHILLER ASIA PACIFIC SDN. BHD. |
|
|
11. |
17/11/2025 |
FA13NOV2025 Alinity ci-series Product Correction - Four (4) potential issues with the Alinity ci‐series System software versions 3.6.1 and lower. |
ALINITY I PROCESSING MODULE |
IVDA3247720-46201 |
ABBOTT LABORATORIES (MALAYSIA) SDN. BHD |
|
|
12. |
17/11/2025 |
Patient Medical History Data Persistence Failure in ViewPointTM 6 versions 6.15.3 and 6.15.4 Ultrasound Software VIEWPOINT 6 (GB9473024-174386) |
VIEWPOINT 6 |
GB9473024-174386 |
GE HEALTHCARE SDN. BHD |
|
|
13. |
18/11/2025 |
FA-25054-B- FA-25054-B - Customer complaints were received for multiple Bicarbonate reagent lots associated with false high patient results for Bicarbonate |
BECKMAN COULTER ELECTROLYTE REAGENTS |
IVDB2268977017 |
BECKMAN COULTER MALAYSIA SDN. BHD. |
|
|
14. |
20/11/2025 |
FA-25078- Beckman Coulter has determined that Access 2 RVs lots listed above may contain manufacturing deformities. The bottom (round end) of the RV may have a small protrusion or hair like deformity. |
Access 2 Immunoassay System |
IVDA9285425-200627 |
BECKMAN COULTER MALAYSIA SDN. BHD. |
|
|
15. |
25/11/2025 |
Incorrect X-Ray output when using dual X-Ray tube after serial radiography selection. |
REMOTE-CONTROLLED R/F SYSTEM |
GC81874835818 |
SHIMADZU MALAYSIA SDN BHD |
|
|
16. |
21/11/2025 |
Deviations of Elecsys® Anti-TSHR assay on cobas® e 411, cobas e 402 and cobas e 801 Device Name: Elecsys® Anti-TSHR assay |
ROCHE DIAGNOSTICS GMBH_IMMUNOCHEMISTRY_THYROID FUNCTION MARKERS |
IVDB6682624-182011 |
ROCHE DIAGNOSTICS (M) SDN. BHD. |
|
|
17. |
26/11/2025 |
Potential severe injury due to unintended disconnection of LAF1000 transfer tube from LLA210-S needle during or after brachytherapy treatment |
HDR AFTERLOADER |
GC37143296817 |
ONCORAY SDN BHD |
|
|
18. |
27/11/2025 |
Unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems, containing certain power management boards, when AC mains power is disconnected or AC mains power is lost CARESTATION 650 A1, CARESTATION 650C A1, CARESTATION 620 A1 (GC5901122-104148) |
CARESTATION 650 A1, CARESTATION 650C A1, CARESTATION 620 A1 |
GC5901122-104148 |
GE HEALTHCARE SDN. BHD |
|
|
19. |
27/11/2025 |
Unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems, containing certain power management boards, when AC mains power is disconnected or AC mains power is lost CARESTATION 700 SERIES (GC2333221-51495) |
CARESTATION 700 SERIES |
GC2333221-51495 |
GE HEALTHCARE 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.
