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MEDICAL DEVICE FIELD CORRECTIVE ACTION LISTING JANUARY 2026
The list below contains Medical Device’s Field Corrective Action for the month of January 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 JANUARY 2026
|
No. |
Date Received |
Title of FCA |
Affected Medical Device |
MDA Reference Number |
MDA Registration Number |
Local Establishment Contact Detail |
|
1 |
02/01/2026 |
Olympus to Emphasizes Compliance to the IFU and System Manual & To Provide Additional Instructions |
RESECTOSCOPE SYSTEM |
GC75601857218 |
OLYMPUS (MALAYSIA) SDN. BHD. |
|
|
2 |
02/01/2026 |
Olympus to Repair the Miswiring |
SHOCKPULSE-SE LITHOTRIPSY SYSTEM |
GC92154340917 |
OLYMPUS (MALAYSIA) SDN. BHD. |
|
|
3 |
07/01/2026 |
Zimmer Air Dermatomes - Dermatome Thickness Control Bar Misalignment |
ZIMMER AIR DERMATOMES |
GB96045673518 |
ZIMMER MEDICAL (MALAYSIA) SDN BHD |
|
|
4 |
07/01/2026 |
SPRINTER CART (XL) – Missing ‘Pushing prohibited’ label |
ROTAFLOW II SYSTEM |
GC7519323-144960 |
RBD HEALTHCARE SDN BHD |
|
|
5 |
27/01/2026 |
AEROSOL MASK (ADULT) WITH CONNECTING TUBE 2.5M, LESS AND SLOW MIST OUTPUT. |
AEROSOL MASK WITH CONNECTING TUBE |
GB9722022-110907 |
MYMEDIC INNOVATION SDN BHD |
|
|
6 |
29/01/2026 |
AEROSOL MASK (ADULT) WITH CONNECTING TUBE 2.5M, NO MIST OUTPUT. |
AEROSOL MASK WITH CONNECTING TUBE |
GB9722022-110907 |
MYMEDIC INNOVATION SDN BHD |
|
|
7 |
29/01/2026 |
AEROSOL MASK (ADULT) WITH CONNECTING TUBE 2.5M, LESS AND SLOW MIST OUTPUT. |
AEROSOL MASK WITH CONNECTING TUBE |
GB9722022-110907 |
MYMEDIC INNOVATION SDN BHD |
|
|
8 |
13/01/2026 |
To advise the details of the shelf life discrepancy and what actions to be taken, should device labelling indicate the discrepancy - Gelweave |
GELWEAVE VASCULAR PROSTHESIS |
GD94369461417 |
TERUMO MALAYSIA SDN. BHD. |
|
|
9 |
13/01/2026 |
To advise the details of the shelf life discrepancy and what actions to be taken, should device labelling indicate the discrepancy - Gelsoft Plus |
GELSOFT PLUS VASCULAR PROSTHESIS |
GD43852800518 |
TERUMO MALAYSIA SDN. BHD. |
|
|
10 |
14/01/2026 |
Cybersecurity vulnerability affecting Centricity RIS-i configured with Instant Messenger |
Centricity RIS-i |
GA1620121-61938 |
GE HEALTHCARE SDN. BHD |
|
|
11 |
28/01/2026 |
2024-IGT-BST-020 - Philips Azurion systems unexpected table movement |
AZURION 3 |
GC99381544218 |
PHILIPS MALAYSIA SENDIRIAN BERHAD |
|
|
12 |
28/01/2026 |
2024-IGT-BST-020 - Philips Azurion systems unexpected table movement |
AZURION 5 |
GC10785320-48186 |
PHILIPS MALAYSIA SENDIRIAN BERHAD |
|
|
13 |
28/01/2026 |
2024-IGT-BST-020 - Philips Azurion systems unexpected table movement |
AZURION 7 |
GC82521235717 |
PHILIPS MALAYSIA SENDIRIAN BERHAD |
|
|
14 |
28/01/2026 |
2024-IGT-BST-020 - Philips Azurion systems unexpected table movement |
AZURION BIPLANE |
GC59959884718 |
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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