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MEDICAL DEVICE FIELD CORRECTIVE ACTION LISTING MAY 2026
The list below contains Medical Device’s Field Corrective Action for the month of May 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 MAY 2026
|
No. |
Date Received |
Title of FCA |
Affected Medical Device |
MDA Reference Number |
MDA Registration Number |
Local Establishment Contact Detail |
|
1 |
04/05/2026 |
HIGH LEVEL DISINFECTANT 5L WITH 0.15% PERACETIC ACID WITH ISSUE OF EXCESSIVE ODOUR, BUBBLE, CORROSION AND DISCOLORATION |
HIGH LEVEL DISINFECTANT PERACETIC ACID |
GC7485024-157847 |
MYMEDIC INNOVATION SDN BHD |
|
|
2 |
05/05/2026 |
2025-IGT-BST-005 Philips Azurion Potential loss of imaging functionality (Allura/Azurion) |
AZURION 3 |
GC99381544218 |
PHILIPS MALAYSIA SENDIRIAN BERHAD |
|
|
3 |
05/05/2026 |
2025-IGT-BST-005 Philips Azurion Potential loss of imaging functionality (Allura/Azurion) |
AZURION 7 |
GC82521235717 |
PHILIPS MALAYSIA SENDIRIAN BERHAD |
|
|
4 |
05/05/2026 |
2025-IGT-BST-005 Philips Azurion Potential loss of imaging functionality (Allura/Azurion) |
AZURION BIPLANE |
GC59959884718 |
PHILIPS MALAYSIA SENDIRIAN BERHAD |
|
|
5 |
05/05/2026 |
FSCA – Genexus Dx Software Cybersecurity Vulnerability |
Genexus™ Dx Integrated Sequencer |
MDA/FCA/P1776-98445959-2026 |
IVDA7155723-146952 |
BIOMARKETING SERVICES (M) SDN BHD |
|
6 |
06/05/2026 |
Windows license activation of Internet connection from Sysmex Analyzer |
AUTOMATED HEMATOLOGY ANALYZER XN SERIES |
IVDB4650226-222618 |
SYSMEX (MALAYSIA) SDN. BHD. |
|
|
7 |
08/05/2026 |
030 FSCA AIMC 25-06 2nd Follow Up Atellica IM and ADVIA Centaur Homocysteine Calibrator | Atellica IM and ADVIA Centaur Homocysteine Calibrator Instability |
ATELLICA® IM HOMOCYSTEINE (HCY) |
IVDB59216279518 |
SIEMENS HEALTHCARE SDN. BHD. |
|
|
8 |
12/05/2026 |
User Manual Update for TU2000 TRYTABLE |
MMT TRYTABLE TU2000 |
GA2807724-178157 |
MEDI-LIFE (M) SDN. BHD. |
|
|
9 |
12/05/2026 |
Merlin Programmer Pacing Capture Test in Aveir Leadless Pacer |
MERLIN PATIENT CARE SYSTEM & PACING SYSTEM ANALYZER |
GC9743622-98481 |
ABBOTT MEDICAL (MALAYSIA) SDN. BHD. |
|
|
10 |
12/05/2026 |
031 CN ACHC 24-06 Follow Up Atellica CH Lactate_3 | Resolution of Atellica CH Lactate_3 (Lac_3) Onboard Reagent Instability |
ATELLICA® CH LACTATE_3 (LAC_3) |
IVDB5904622-106142 |
SIEMENS HEALTHCARE SDN. BHD. |
|
|
11 |
14/05/2026 |
IntelliCuff (Standalone) – Cuff System Leakage and Continuous Pumping Issue |
HAMILTON-INTELLICUFF |
GC561911093218 |
STAR MEDIK SDN BHD |
|
|
12 |
14/05/2026 |
CASETM v7– Thermal Printer Assembly [CASE CARDIAC TESTING SYSTEM |
CASE CARDIAC TESTING SYSTEM |
MDA/FCA/P1798-12235854-2026 |
GB64876396017 |
GE HEALTHCARE SDN. BHD |
|
13 |
14/05/2026 |
ApexPro CARESCAPE Telemetry Server v5.0 and v6.0 with CARESCAPE Central Station or CIC Pro Clinical Information Center |
APEXPRO TELEMETRY SYSTEM |
GC96351485517 |
GE HEALTHCARE SDN. BHD |
|
|
14 |
15/05/2026 |
032 CN AIMC 24-03 Follow Up Atellica IM Rubella IgG (Rub G) and ADVIA Centaur Rubella G | Resolution: Potential for Invalid Calibrations with Atellica IM and ADVIA Centaur Systems Rubella IgG Assay |
ATELLICA® IM RUBELLA IGG (RUB G) |
IVDC17674265918 |
SIEMENS HEALTHCARE SDN. BHD. |
|
|
15 |
20/05/2026 |
Field Safety Corrective Action (FSCA) / Voluntary Medical Device Recall (Correction) for Automated Impella Controller (AIC) and Impella Optical Controller – Potential Software Error Causing Unexpected System Restart and Temporary Pump Stop |
IMPELLA CP® WITH SMARTASSIST® SET |
GD9474523-140294 |
DCH AURIGA (M) SDN BHD |
|
|
16 |
20/05/2026 |
AX018/26/S (FSCA) & AX019/26/S (CSI) - SW Update VE40B Patch5 |
ARTIS ICONO FAMILY |
GC7669520-43102 |
SIEMENS HEALTHCARE SDN. BHD. |
|
|
17 |
21/05/2026 |
O-arm™ O2 Imaging System Detector Panel Firmware Update (Identifier: BI-700-02000) (FA1542) |
O-ARM O2 IMAGING SYSTEM AND ACCESSORIES |
GC10794122-104946 |
MEDTRONIC MALAYSIA SDN BHD |
|
|
18 |
26/05/2026 |
To advise discrepancies between the Operation Manual and the device screen prompts, to enhance the information for the users - Terumo Recording & Automatic Blood Collector |
TERUMO RECORDING & AUTOMATIC BLOOD COLLECTOR |
GA12928200617 |
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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