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MEDICAL DEVICE FIELD CORRECTIVE ACTION LISTING APRIL 2026
The list below contains Medical Device’s Field Corrective Action for the month of April 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 APRIL 2026
|
No. |
Date Received |
Title of FCA |
Affected Medical Device |
MDA Reference Number |
MDA Registration Number |
Local Establishment Contact Detail |
|
1 |
07/04/2026 |
VITROS™ Chemistry Products Mg Slides May Not Meet On-Analyzer Stability Specification |
VITROS CHEMISTRY PRODUCTS ELECTROLYTES REAGENTS |
GD9627525-205666 |
T T MEDICAL MANAGEMENT SDN BHD |
|
|
2 |
09/04/2026 |
2024-PD-MR-016 Philips MR system breast coils Potential for harm while using a breast coil |
MR 5300 |
GC4777625-217427 |
PHILIPS MALAYSIA SENDIRIAN BERHAD |
|
|
3 |
14/04/2026 |
Field Safety Notification for Flexitron System - Intrauterine tube (IU tube) |
FLEXITRON SYSTEM |
MDA/FCA/P1736-94420885-2026 |
IVDC51660257518 |
NYPRAX BUSINESS SOLUTIONS |
|
4 |
09/04/2026 |
FA1536 SynchroMed Flex Infusion Mode - A810 Clinician Programmer Application |
SYNCHROMED II PROGRAMMABLE PUMP SYSTEM AND ACCESSORIES |
GB7982922-110702 |
MEDTRONIC MALAYSIA SDN BHD |
|
|
5 |
13/04/2026 |
Field Safety Action on weak or absent staining associated with specific lots of Artisan Periodic Acid-Schiff Stain Kit (AR165), Artisan Alcian Blue/PAS Stain Kit (AR169), Artisan PAS Green Stain Kit (AR172), and Artisan Alcian Blue/PAS/Hematoxylin Stain Kit (AR178) |
DAKO_HISTOLOGY/CYTOLOGY_HISTOLOGY/CYTOLOGY REAGENTS_ARTISAN SPECIAL STAIN |
GC2975220-43026 |
BITA LIFESCIENCE SDN. BHD. |
|
|
6 |
13/04/2026 |
Voluntary Recall for InZone Detachment System due to Premature Battery Drainage |
INZONE DETACHMENT SYSTEM |
MDA/FCA/P1746-54168593-2026 |
GC84604193017 |
STRYKER CORPORATION (MALAYSIA) SDN. BHD. |
|
7 |
13/04/2026 |
MR015/25/P (CAN) - Distribution of a Customer Advisory Notice to inform MR customers that Siemens Healthineers has incorporated a mandatory visual inspection and improved helium leak check of the venting system into the routine annual maintenance procedure, with clear intervention criteria for when to de ice the magnet via established service procedures |
MAGNETOM PRISMA |
GC5206022-82422 |
SIEMENS HEALTHCARE SDN. BHD. |
|
|
8 |
17/04/2026 |
ETC Beadchip Kit Exposure Test Carrier Low Signal Results in BeadChipTM Assays |
PRECISETYPE HEA MOLECULAR BEADCHIP TEST |
GC13082609918 |
BMS DIAGNOSTICS (M) SDN BHD |
|
|
9 |
17/04/2026 |
Blood Pressure Monitor YE660E with the situation where the information of the Outdated Labelling, QR Code Discrepancy and Labelling / IFU Compliance |
YUWELL ELECTRONIC BLOOD PRESSURE MONITOR |
GD17535444617 |
RBD HEALTHCARE SDN BHD |
|
|
10 |
20/04/2026 |
da Vinci X, Xi Systems Cannula Mount Screws Breakage |
DA VINCI XI SURGICAL SYSTEM, ENDOSCOPIC INSTRUMENT CONTROL SYSTEM, MODEL IS4000 |
GB18651834218 |
DTG MEDICAL SDN BHD |
|
|
11 |
20/04/2026 |
Xpert Carba-R incorrect shipment to Malaysia |
XPERT CARBA-R ASSAY |
GC82521235717 |
RADIOMETER MALAYSIA SDN. BHD. |
|
|
12 |
22/04/2026 |
ABL800 - Cybersecurity vulnerabilities |
ABL8XX SERIES BLOOD GAS ANALYZERS |
GC59959884718 |
RADIOMETER MALAYSIA SDN. BHD. |
|
|
13 |
22/04/2026 |
ABL90 FLEX & ABL90 FLEX PLUS - Cybersecurity vulnerabilities |
ABL90 FLEX |
GD958991229918 |
RADIOMETER MALAYSIA SDN. BHD. |
|
|
14 |
27/04/2026 |
Potential failure of the mechanical ventilation – Extension of TSB13 (MDA/FCA/P1007-13171759-2024) |
ATLAN |
GC4930621-68598 |
DRAEGER MALAYSIA SDN BHD |
|
|
15 |
28/04/2026 |
Olympus to Provide Update on Instruction for Use (IFU). |
SINGLE LIGATION DEVICE_HX-400U-30 |
GD69454346817 |
OLYMPUS (MALAYSIA) SDN. BHD. |
|
|
16 |
29/04/2026 |
2025-IGT-BST-020 - Philips Allura and Azurion systems Deaeration hose of tube cooling unit may degrade over time and develop oil leakage, potentially leading to loss of imaging functionality or exposure of users and/or patients to fumes |
AZURION 3 |
GC92659835718 |
PHILIPS MALAYSIA SENDIRIAN BERHAD |
|
|
17 |
29/04/2026 |
2025-IGT-BST-020 - Philips Allura and Azurion systems Deaeration hose of tube cooling unit may degrade over time and develop oil leakage, potentially leading to loss of imaging functionality or exposure of users and/or patients to fumes |
AZURION 7 |
GC98026871418 |
PHILIPS MALAYSIA SENDIRIAN BERHAD |
|
|
18 |
29/04/2026 |
2025-IGT-BST-020 - Philips Allura and Azurion systems Deaeration hose of tube cooling unit may degrade over time and develop oil leakage, potentially leading to loss of imaging functionality or exposure of users and/or patients to fumes |
AZURION BIPLANE |
GC91655727318 |
PHILIPS MALAYSIA SENDIRIAN BERHAD |
|
|
19 |
29/04/2026 |
2024-IGT-PUN-009 Zenition 10 Arcing in X-ray tube potentially leading to temporary loss of imaging functionality |
ZENITION 10 |
GB4127824-160695 |
PHILIPS MALAYSIA SENDIRIAN BERHAD |
|
|
20 |
30/04/2026 |
2024-IGT-BST-023 Philips Azurion Systems Mechanical wear of the Float Tabletop control potentially leading to limited availability or loss of longitudinal and transverse table movements and/or lacerations |
AZURION 3 |
IVDB7126524-184610 |
PHILIPS MALAYSIA SENDIRIAN BERHAD |
|
|
21 |
30/04/2026 |
2024-IGT-BST-023 Philips Azurion Systems Mechanical wear of the Float Tabletop control potentially leading to limited availability or loss of longitudinal and transverse table movements and/or lacerations |
AZURION 7 |
IVDA9233125-201119 |
PHILIPS MALAYSIA SENDIRIAN BERHAD |
|
|
22 |
30/04/2026 |
2024-IGT-BST-023 Philips Azurion Systems Mechanical wear of the Float Tabletop control potentially leading to limited availability or loss of longitudinal and transverse table movements and/or lacerations |
AZURION BIPLANE |
IVDA9233125-201119 |
PHILIPS MALAYSIA SENDIRIAN 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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