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MEDICAL DEVICE FIELD CORRECTIVE ACTION LISTING MARCH 2026
The list below contains Medical Device’s Field Corrective Action for the month of March 2026. 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 MARCH 2026
|
No. |
Date Received |
Title of FCA |
Affected Medical Device |
MDA Reference Number |
MDA Registration Number |
Local Establishment Contact Detail |
|
1 |
02/03/2026 |
2024-IGT-BST-026 - Philips Azurion potential loss of imaging functionality resulting from no or intermittent X-ray radiation initiation through the wired foot switch. |
AZURION 3 |
GC99381544218 |
PHILIPS MALAYSIA SENDIRIAN BERHAD |
|
|
2 |
03/03/2026 |
2024-IGT-BST-026 - Philips Azurion potential loss of imaging functionality resulting from no or intermittent X-ray radiation initiation through the wired foot switch. |
AZURION 5 |
GC10785320-48186 |
PHILIPS MALAYSIA SENDIRIAN BERHAD |
|
|
3 |
03/03/2026 |
2024-IGT-BST-026 - Philips Azurion potential loss of imaging functionality resulting from no or intermittent X-ray radiation initiation through the wired foot switch. |
AZURION 7 |
GC82521235717 |
PHILIPS MALAYSIA SENDIRIAN BERHAD |
|
|
4 |
03/03/2026 |
2024-IGT-BST-026 - Philips Azurion potential loss of imaging functionality resulting from no or intermittent X-ray radiation initiation through the wired foot switch. |
AZURION BIPLANE |
GC59959884718 |
PHILIPS MALAYSIA SENDIRIAN BERHAD |
|
|
5 |
04/03/2026 |
Field Corrective Action on Precipitates Forming in the Reconstitution Buffer within the Test Cartridge of Afinion HbA1c |
AFINION HBA1C |
IVDB67848304818 |
ABBOTT DIAGNOSTICS HEALTH SDN BHD |
|
|
6 |
05/03/2026 |
2025-EI-RI-003 - Vue Motion V12 Potential for misdiagnosis due to multi-frame images displaying out of sequence |
PHILIPS VUE PACS |
GB18651834218 |
PHILIPS MALAYSIA SENDIRIAN BERHAD |
|
|
7 |
06/03/2026 |
Field Safety Corrective Action: Purge Cassette (Generation 1) for Impella System – Increased Risk of Purge Leak Leading to Low Purge Pressure |
IMPELLA CP® WITH SMARTASSIST® SET |
GD9474523-140294 |
DCH AURIGA (M) SDN BHD |
|
|
8 |
13/03/2026 |
The value assignment of certain HemosIL Heparin Calibrator lots showed a bias against the WHO International Standards for UFH and LMWH, which could have resulted in reduced recovery when measuring heparin in controls and patient samples. |
HEMOSIL LIQUID ANTI-XA |
IVDC53329234618 |
STRAITS SCIENTIFIC (M) SDN BHD |
|
|
9 |
18/03/2026 |
Olympus to Remind Customers of HF Cable IFU Information. |
ELECTROSURGICAL GENERATOR ESG-400 |
GC94229142417 |
OLYMPUS (MALAYSIA) SDN. BHD. |
|
|
10 |
19/03/2026 |
FA1546 Induction of ventricular arrythmia during Sphere-9™ catheter radiofrequency ablation in patients with Biotronik ICDs |
AFFERA™ INTEGRATED MAPPING SYSTEM |
GD9452125-218019 |
MEDTRONIC MALAYSIA SDN BHD |
|
|
11 |
24/03/2026 |
023 FSCA ACHC 26-05 Atellica CH Creatine Kinase (CK_L) | Potential for Falsely Elevated Results with Lot Numbers 252591, 252602 and 252612 |
ATELLICA® CH CREATINE KINASE (CK_L) |
IVDC9131423-128501 |
SIEMENS HEALTHCARE SDN. BHD. |
|
|
12 |
25/03/2026 |
024 CN AIMC 26-02 Atellica IM and ADVIA Centaur Free Prostate-Specific Antigen (fPSA) | Invalid Calibrations |
ATELLICA® IM FREE PROSTATE‑SPECIFIC ANTIGEN (FPSA) |
IVDC82776266818 |
SIEMENS HEALTHCARE SDN. BHD. |
|
|
13 |
26/03/2026 |
Documentation Omission in LIAISON Rubella IgM, 310730 (Missing NFTU) |
LIAISON® RUBELLA IGM |
IVDC8532923-128419 |
DIAGNOSTICARE SDN BHD |
|
|
14 |
26/03/2026 |
022 FSCA DC 26-01 Dimension Creatinine Flex Reagent Cartridge| Imprecision with Quality Control and Patient Results for Dimension Creatinine Lot Numbers GA6307 and BA7005 |
DIMENSION CREATININE |
IVDB54125130718 |
SIEMENS HEALTHCARE SDN. BHD. |
|
|
15 |
27/03/2026 |
Software Anomaly Causing VITROS™ Systems to Switch From VITROS™ Calibrator Kit 32 to VITROS™ Calibrator Kit 2 During ADD Load |
VITROS IMMUNODIAGNOSTIC PRODUCTS FERTILITY & PREGNANCY HORMONES & PROTEINS |
IVDB7258323-129195 |
T T MEDICAL MANAGEMENT SDN BHD |
|
|
16 |
27/03/2026 |
Reduced Shelf Life of PALAMIX® Mixing System |
PALAMIX VACUUM MIXING SYSTEM |
MDA/FCA/P1726-81262285-2026 ( Attachment A ) ( Attachment B ) |
GB4398519-36101 |
ACX HEALTH SDN. BHD. |
|
17 |
30/03/2026 |
2025-IGT-BST-025 Aneurysm Flow Potential Safety issue if MAFA ratio is used for clinical decision making |
ANEURYSMFLOW |
GB16499497817 |
PHILIPS MALAYSIA SENDIRIAN BERHAD |
|
|
18 |
30/03/2026 |
To advise of updates to the Instructions for Use (IFU) to enhance the information for the users - Thoraflex Hybrid |
THORAFLEX HYBRID DEVICE |
GD79535860718 |
TERUMO 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.
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