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MEDICAL DEVICE FIELD CORRECTIVE ACTION LISTING DECEMBER 2025
The list below contains Medical Device’s Field Corrective Action for the month of December 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 DECEMBER 2025
|
No. |
Date Received |
Title of FCA |
Affected Medical Device |
MDA Reference Number |
MDA Registration Number |
Local Establishment Contact Detail |
|
1 |
12/12/2025 |
KERR ENDODONTICS K-FILES HAND FILES - Field Safety Notice to correct IFU for cleaning time and typos |
KERR ENDODONTICS K-FILES HAND FILES |
GA2877324-180637 |
EHC COMMERCIAL MALAYSIA SDN. BHD. |
|
|
2 |
12/12/2025 |
KERR ENDODONTICS HEDSTROM HAND FILES - Field Safety Notice to correct IFU for cleaning time and typos |
KERR ENDODONTICS HEDSTROM HAND FILES |
GC81874835818 |
EHC COMMERCIAL MALAYSIA SDN. BHD. |
|
|
3 |
09/12/2025 |
A potential issue was identified where the electromagnetic contactors are welded in the cabinet of the X-ray high-voltage generator, due to age degradation may cause continuous current flow even after shutdown, leading to possible overheating and device damage; a field corrective action will be implemented to prevent this. |
REMOTE-CONTROLLED R/F SYSTEM |
GD9627525-205666 |
SHIMADZU MALAYSIA SDN BHD |
|
|
4 |
01/12/2025 |
Intracranial Pressure Monitor Pressio 2 Monitor Reboot Issue Due to Catheter Memory Corruption |
PRESSIO INTRACRANIAL PRESSURE AND TEMPERATURE MONITORING SYSTEM |
GC4777625-217427 |
I.MEDIC PLT |
|
|
5 |
01/12/2025 |
Unexpected shutdown of Carestation 700 Series Anesthesia Systems, containing certain power management boards, when AC mains power is disconnected or AC mains power is lost CARESTATION 700 SERIES (GC4777625-217427) |
CARESTATION 700 SERIES |
IVDC51660257518 |
GE HEALTHCARE SDN. BHD |
|
|
6 |
02/12/2025 |
Xpert® CT/NG assays false negative due to escape mutants |
XPERT CT/NG |
GB7982922-110702 |
RADIOMETER MALAYSIA SDN. BHD. |
|
|
7 |
02/12/2025 |
Laerdal Compact Suction Unit 4, RTCA (LCSU 4 – RTCA) Version emitting beyond the acceptable limits for RTCA application specified in RTCA DO-160G Chapter 21, Equipment Category M |
LAERDAL COMPACT SUCTION UNIT 4 (LCSU 4) |
IVDC74609321918 |
LAERDAL MALAYSIA SDN BHD |
|
|
8 |
05/12/2025 |
Xpert® BCR-ABL Ultra False Under Quantitation |
XPERT BCR-ABL ULTRA |
GC2975220-43026 |
RADIOMETER MALAYSIA SDN. BHD. |
|
|
9 |
03/12/2025 |
2025-CC-HPM-033 - IntelliVue Patient Monitor MX850, MX750, Active Display AD85 and Active Display AD75 - Potential for delayed treatment or adverse events when switching off Patient Monitor Alarms |
INTELLIVUE PATIENT MONITOR MX750 & MX850 |
GC84604193017 |
PHILIPS MALAYSIA SDN BERHAD |
|
|
10 |
03/12/2025 |
2025-CC-HPM-033 - IntelliVue Patient Monitor MX400, MX450, MX500, MX550 & IntelliVue MMX - Potential for delayed treatment or adverse events when switching off Patient Monitor Alarms |
INTELLIVUE PATIENT MONITOR MX400-550 SERIES |
GC5206022-82422 |
PHILIPS MALAYSIA SDN BERHAD |
|
|
11 |
03/12/2025 |
2025-CC-HPM-033 - IntelliVue Patient Monitor MX100 & IntelliVue Multi-Measurement Module X3 - Potential for delayed treatment or adverse events when switching off Patient Monitor Alarms |
INTELLIVUE MX100 AND X3 |
GC13082609918 |
PHILIPS MALAYSIA SDN BERHAD |
|
|
12 |
04/12/2025 |
2025-CC-HPM-033 - INTELLIVUE MP5 - Potential for delayed treatment or adverse events when switching off Patient Monitor Alarms |
INTELLIVUE MP5, MP5T & MP5SC PATIENT MONITOR |
GD17535444617 |
PHILIPS MALAYSIA SDN BERHAD |
|
|
13 |
16/12/2025 |
Safety Information to inform customers about the correct handling and use of the MINOP® TROCAR - FF399R. |
AESCULAP SURGICAL INSTRUMENT NEUROSURGERY |
GB18651834218 |
B. BRAUN MEDICAL INDUSTRIES SDN. BHD. |
|
|
14 |
05/12/2025 |
2025-EI-RI-004 - Vue PACS (Diagnostic) and Vue Motion version 12.2.8.600 - Potential for misdiagnosis due to Bookmark not preserving the original measurement specified by the user upon subsequent access following version 12.2.8.600 upgrade. |
PHILIPS VUE PACS |
GC82521235717 |
PHILIPS MALAYSIA SDN BERHAD |
|
|
15 |
09/12/2025 |
2025-IGT-BST-013 Philips Azurion R3.0 Systems Potential loss of imaging (X-ray) functionality, and/or loss of motorized movement, and/or incorrect image content, and/or loss of data which may result in a delay or termination of procedure and/or procedural complications |
AZURION 7 |
GC59959884718 |
PHILIPS MALAYSIA SDN BERHAD |
|
|
16 |
09/12/2025 |
2025-IGT-BST-013 Philips Azurion R3.0 Systems Potential loss of imaging (X-ray) functionality, and/or loss of motorized movement, and/or incorrect image content, and/or loss of data which may result in a delay or termination of procedure and/or procedural complications |
AZURION BIPLANE |
GD958991229918 |
PHILIPS MALAYSIA SDN BERHAD |
|
|
17 |
09/12/2025 |
Advice on Instructions for Use of BK Medical Ultrasound system type 1300 with Battery Option |
BK1300 BKSPECTO ULTRASOUND SCANNER SYSTEMS |
GC4930621-68598 |
MEDI-LIFE (M) SDN. BHD. |
|
|
18 |
09/12/2025 |
A potential issue was identified where the electromagnetic contactors are welded in the cabinet of the X-ray high-voltage generator, due to age degradation may cause continuous current flow even after shutdown, leading to possible overheating and device damage; a field corrective action will be implemented to prevent this. |
RADSPEED PRO |
GD69454346817 |
SHIMADZU MALAYSIA SDN BHD |
|
|
19 |
09/12/2025 |
Advice on Instructions for Use of BK Medical Ultrasound system type 2300 with Battery Option |
BK MEDICAL BK2300 ULTRASOUND SCANNER SYSTEM |
GC92659835718 |
MEDI-LIFE (M) SDN. BHD. |
|
|
20 |
09/12/2025 |
A potential issue was identified where the electromagnetic contactors are welded in the cabinet of the X-ray high-voltage generator, due to age degradation may cause continuous current flow even after shutdown, leading to possible overheating and device damage; a field corrective action will be implemented to prevent this. |
X-RAY TV SYSTEM |
GC98026871418 |
SHIMADZU MALAYSIA SDN BHD |
|
|
21 |
09/12/2025 |
A potential issue was identified where the electromagnetic contactors are welded in the cabinet of the X-ray high-voltage generator, due to age degradation may cause continuous current flow even after shutdown, leading to possible overheating and device damage; a field corrective action will be implemented to prevent this. |
DIGITAL ANGIOGRAPHY SYSTEM |
GC91655727318 |
SHIMADZU MALAYSIA SDN BHD |
|
|
22 |
09/12/2025 |
A potential issue was identified where the electromagnetic contactors are welded in the cabinet of the X-ray high-voltage generator, due to age degradation may cause continuous current flow even after shutdown, leading to possible overheating and device damage; a field corrective action will be implemented to prevent this. |
RADIOGRAPHY SYSTEM |
GB4127824-160695 |
SHIMADZU MALAYSIA SDN BHD |
|
|
23 |
12/12/2025 |
Mazor X™ robotic guidance system Model TPL0059, Software Version 5.0.1 or 5.1.2 or 5.1.3 System Software update to version 5.2 |
MAZOR X SYSTEM AND ACCESSORIES |
IVDB7126524-184610 |
MEDTRONIC MALAYSIA SDN BHD |
|
|
24 |
15/12/2025 |
Automated Digital Cell Morphology Analyzer DI-60 Barcode reader issue |
AUTOMATED DIGITAL CELL MORPHOLOGY ANALYZER DI-60 |
IVDA9233125-201119 |
SYSMEX (MALAYSIA) SDN. BHD. |
|
|
25 |
15/12/2025 |
FA-25079- DxI 600/800 instruments running Windows 10 unexpectedly transition to "Pause/Not Ready" mode due to wash buffer flow monitoring issues, cancelling in-progress tests. This requires users to manually initialize, prime, and reload affected tests, disrupting workflow and diagnostic output |
UniCel DxI Access Immunoassay Systems |
IVDA9233125-201119 |
BECKMAN COULTER MALAYSIA SDN. BHD. |
|
|
26 |
15/12/2025 |
FA-25059- Beckman Coulter UniCel DxI 600 and 800 instruments fail to start after rebooting because the AuObj.exe software does not launch. A specific LED pattern on MCC cards confirms a hardware startup fault. This nonconformance requires FSE intervention. |
UniCel DxI Access Immunoassay Systems |
BECKMAN COULTER MALAYSIA SDN. BHD. |
||
|
27 |
15/12/2025 |
HISCL Anti-TP False Negative Result |
HISCL Anti-TP False Negative Result |
MDA/FCA/P1533-91490848-2025 |
IVDC57839114818 |
SYSMEX (MALAYSIA) SDN. BHD. |
|
28 |
15/12/2025 |
HISCL Anti-TP False Negative Result |
HISCL ANTI-TP ASSAY KIT |
IVDD5667724117 |
SYSMEX (MALAYSIA) SDN. BHD |
|
|
29 |
15/12/2025 |
Replacement with Improved Version of HISCL Anti-HBc Assay Kit |
HISCL ANTI-HBC ASSAY KIT |
IVDC6362721-66356 |
SYSMEX (MALAYSIA) SDN. BHD. |
|
|
30 |
15/12/2025 |
CN series - Sample arm B pipette damage issue |
Sysmex_Automated Coagulation Analyzer_CN Series |
IVDA5543624-159885 |
SYSMEX (MALAYSIA) SDN. BHD. |
|
|
31 |
16/12/2025 |
cobas c 703 Reaction Cell Wash Units Premature Tubing failure |
Cobas Pro integrated solutions |
GC82521235717 |
ROCHE DIAGNOSTICS (M) SDN. BHD. |
|
|
32 |
16/12/2025 |
2025-IGT-BST-012 Philips Azurion R2.1.10 and 2.2.10 Systems Potential loss of imaging (X-ray) functionality, and/or loss of motorized movement, and/or incorrect image content, and/or loss of data which may result in a delay or termination of procedure and/or procedural complications |
AZURION 7 |
GC10785320-48186 |
PHILIPS MALAYSIA SDN BERHAD |
|
|
33 |
16/12/2025 |
2025-IGT-BST-012 Philips Azurion R2.1.10 and 2.2.10 Systems Potential loss of imaging (X-ray) functionality, and/or loss of motorized movement, and/or incorrect image content, and/or loss of data which may result in a delay or termination of procedure and/or procedural complications |
AZURION 5 |
GC99381544218 |
PHILIPS MALAYSIA SDN BERHAD |
|
|
34 |
16/12/2025 |
2025-IGT-BST-012 Philips Azurion R2.1.10 and 2.2.10 Systems Potential loss of imaging (X-ray) functionality, and/or loss of motorized movement, and/or incorrect image content, and/or loss of data which may result in a delay or termination of procedure and/or procedural complications |
AZURION 3 |
GC43835501717 |
PHILIPS MALAYSIA SDN BERHAD |
|
|
35 |
18/12/2025 |
Olympus to Reinforce the Warnings in the IFU |
ELECTROSURGICAL KNIFES |
IVDB10942623-142160 |
OLYMPUS (MALAYSIA) SDN. BHD. |
|
|
36 |
17/12/2025 |
011 FSCA ACHC 24-07 3rd Follow Up Atellica CH Revised C Reactive Protein (RCRP) | Resolution of the Incorrect Software Flagging for the Atellica CH Revised C Reactive Protein (RCRP) Assay on the Atellica CI Analyzer |
ATELLICA® CH REVISED C‑REACTIVE PROTEIN (RCRP) |
GC92154340917 |
SIEMENS HEALTHCARE SDN. BHD. |
|
|
37 |
19/12/2025 |
Olympus to Provide Supplemental Guidance |
SHOCKPULSE-SE LITHOTRIPSY SYSTEM |
IVDB10943324-173555 |
OLYMPUS (MALAYSIA) SDN. BHD. |
|
|
38 |
22/12/2025 |
EliA™ ANA Positive Control 250 & EliA™ ANA Positive Control 200: Update to EliA La Acceptance Range Information |
ELIA METHOD SPECIFIC REAGENTS MARKER |
GC15931545518 |
BIOMARKETING SERVICES (M) SDN BHD |
|
|
39 |
29/12/2025 |
2025-CC-EC-018 - Efficia DFM100 Defibrillator/Monitor (866199) - Boot-Up Failure with SW 2.00.33 |
EFFICIA DFM100 DEFIBRILLATOR |
GA2116024-179663 |
PHILIPS MALAYSIA SDN BERHAD |
* 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.
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