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MEDICAL DEVICE FIELD CORRECTIVE ACTION LISTING JUNE 2026
The list below contains Medical Device’s Field Corrective Action for the month of June 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 JUNE 2026
|
No. |
Date Received |
Title of FCA |
Affected Medical Device |
MDA Reference Number |
MDA Registration Number |
Local Establishment Contact Detail |
|
1 |
02/06/2026 |
1.5cm Spherical Applicators for INTRABEAM (Reference: FCA_OKO_2026_001 IORT Non-Conformance in Batch Release of 1.5cm Spherical Applicators) |
INTRABEAM 600 |
GD779388116 |
CARL ZEISS SDN BHD |
|
|
2 |
03/06/2026 |
Canopy Soffits and fasteners on Giraffe OmniBed and Giraffe OmniBed Carestation Devices GIRAFFE OMNIBED CARESTATION CS1 (GC36600486117) |
GIRAFFE OMNIBED CARESTATION CS1 |
GC36600486117 |
GE HEALTHCARE SDN. BHD |
|
|
3 |
03/06/2026 |
AW Server 3.2 ext. 6.5 – Potential Patient Context Synchronization Issue AW SERVER 3.2 (GB3800423-134964) |
AW SERVER 3.2 |
GB3800423-134964 |
GE HEALTHCARE SDN. BHD |
|
|
4 |
05/06/2026 |
FA1567 Rev A Bio-Medicus™ Adult Cannula Kit Potential Contaminated product |
BIO-MEDICUS™ FEMORAL PERCUTANEOUS CANNULA KIT |
GB2264623-129875 |
MEDTRONIC MALAYSIA SDN BHD |
|
|
5 |
08/06/2026 |
ELLA-CS, s.r.o. initiates voluntary Field Safety Corrective Action concerning the products Danis Procedure Pack – Basic and Danis Procedure Pack |
SX-ELLA STENT DANIS (DANIS STENT) |
MDA/FCA/P1817-21414090-2026 |
GC2594924-183987 |
VITRAMED MALAYSIA SDN. BHD. |
|
6 |
09/06/2026 |
2025-PD-MR-011 MR systems with SW versions R11.1 and R12.1 MobiView cross reference alignment errors |
MR 5300 |
GB2458922-104130 |
PHILIPS MALAYSIA SENDIRIAN BERHAD |
|
|
7 |
10/06/2026 |
037 FSCA ACHC 26-06 Atellica CH Enzymatic Hemoglobin A1c (A1c_E) | Potential for Well-to-Well Shifts Impacting Atellica CH A1c_E |
ATELLICA® CH ENZYMATIC HEMOGLOBIN A1C (A1C_E) |
IVDB9845619-35149 |
SIEMENS HEALTHCARE SDN. BHD. |
|
|
8 |
12/06/2026 |
Polyaxial & reduction screwdriver assembly - functional defect on the threaded part |
VEOS |
GC7424624-168464 |
SYNERGIC EVOLUTION SDN BHD |
|
|
9 |
12/06/2026 |
2026-CC-HPM-001 - Philips Avalon Fetal Monitor Incorrect Assembly of Speaker Connector |
AVALON FETAL MONITORS |
GC95268545118 |
PHILIPS MALAYSIA SENDIRIAN BERHAD |
|
|
10 |
15/06/2026 |
Notice of Revision to LCMS CLAM-2030 CL Specification Wording. |
Fully Automated Sample Preparation Module for LCMS |
IVDA7288821-81276 |
SHIMADZU MALAYSIA SDN BHD |
|
|
11 |
15/06/2026 |
Olympus to Provide Offset Adjustment for UHI-4 Pressure Sensors |
HIGH FLOW INSUFFLATION UNIT |
GB929511113418 |
OLYMPUS (MALAYSIA) SDN. BHD. |
|
|
12 |
16/06/2026 |
Urgent Medical Device Recall (Correction): Potential Introducer Sheath Leakage in Impella Introducer Kits (14Fr and 23Fr) Used with Impella Heart Pumps |
IMPELLA CP® WITH SMARTASSIST® SET |
GD9474523-140294 |
DCH AURIGA (M) SDN BHD |
|
|
13 |
18/06/2026 |
Customer Advisory Notice CT018/25/P - Incorrect DLP value displayed and recorded in DICOM data |
SOMATOM X.CITE |
MDA/FCA/P1835-27645955-2026 |
GC5563225-208447 |
SIEMENS HEALTHCARE SDN. BHD. |
|
14 |
19/06/2026 |
FSCA- OncomineTM Dx Express Test Panel |
ONCOMINE DX EXPRESS TEST |
IVDC8307123-151995 |
BIOMARKETING SERVICES (M) SDN BHD |
|
|
15 |
23/06/2026 |
2025-IGT-BST-018 Philips Azurion Potential loss of imaging functionality due to unauthorized Hard Disk Drives |
AZURION 7 |
GC82521235717 |
PHILIPS MALAYSIA SENDIRIAN BERHAD |
|
|
16 |
23/06/2026 |
2025-IGT-BST-018 Philips Azurion Potential loss of imaging functionality due to unauthorized Hard Disk Drives |
AZURION BIPLANE |
GC59959884718 |
PHILIPS MALAYSIA SENDIRIAN BERHAD |
|
|
17 |
24/06/2026 |
Astral 100/150 – Ventilator may stop delivering therapy due to internal component issue |
ASTRAL |
GC65216272017 |
RESMED MALAYSIA OPERATIONS SDN. BHD. |
|
|
18 |
25/06/2026 |
Advice on Instructions for Use (IFU) for the AirSeal® Access Ports |
AIRSEAL® IFS INTELLIGENT FLOW SYSTEM |
GB5554822-110272 |
MEDI-LIFE (M) SDN. BHD. |
|
|
19 |
26/06/2026 |
EliA™ ANA Positive Control 250: Update to EliA Ro60 & EliA dsDNA Acceptance Range Information |
ELIA METHOD SPECIFIC REAGENTS MARKER |
IVDB10943324-173555 |
BIOMARKETING SERVICES (M) 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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