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MEDICAL DEVICE FIELD CORRECTIVE ACTION LISTING JULY 2026
The list below contains Medical Device’s Field Corrective Action for the month of July 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 JULY 2026
|
No. |
Date Received |
Title of FCA |
Affected Medical Device |
MDA Reference Number |
MDA Registration Number |
Local Establishment Contact Detail |
|
1 |
01/07/2026 |
FA1546 Rev C - Wave 3 Induction of ventricular arrythmia during Sphere-9™ catheter radiofrequency ablation in patients with Biotronik ICD/CRT-D Sphere-9™ Catheter |
AFFERA™ INTEGRATED MAPPING SYSTEM |
GD9452125-218019 |
MEDTRONIC MALAYSIA SDN BHD |
|
|
2 |
03/07/2026 |
EliA ANA Positive Control 200: Update to EliA La Acceptance Range Information |
ELIA PHADIA 200 CONTROLS |
IVDB2265720-49554 |
BIOMARKETING SERVICES (M) SDN BHD |
|
|
3 |
07/07/2026 |
NOxBOXi Nitric Oxide Delivery Devices software update to V18.6 |
SCHMIDT BIOMEDTECH SDN BHD |
|||
|
4 |
06/07/2026 |
Field Corrective Action Report for Ø3.5 mm Cortical Screw (Product Code: 2040050, Lot No. 041925-09-V). |
PLATE AND SCREW |
GC34418957118 |
OSA TECHNOLOGY SDN. BHD. |
|
|
5 |
08/07/2026 |
Resolution of software-related system responses (Patient Safe, Failsafe, false alarm) Software Update for the LEONI 4 Ventilator |
LEONI VENTILATORS |
GC2172425-219272 |
SCHMIDT BIOMEDTECH SDN BHD |
|
|
6 |
10/07/2026 |
FSCA 041 CN 26-007 DCA Vantage HbA1c Atellica DCA HbA1c Monitor Kit DCA Vantage HbA1c | HbA1c Reagent Cartridge Bias Issue due to Delamination |
DCA VANTAGE SYSTEM |
IVDB8945423-128502 |
SIEMENS HEALTHCARE SDN. BHD. |
|
|
7 |
14/07/2026 |
Urine Meter (500ml) with 2000ml Drainage Bag have manufacturing defect |
URINE METER 2000ML |
GMD76630876718A |
FORESIGHT INDUSTRIES SDN BHD |
|
|
8 |
24/07/2026 |
Possible delivery of a lower oxygen concentration than set - Oxylog 600 |
DRAEGER MALAYSIA SDN BHD |
|||
|
9 |
17/07/2026 |
UD-10: Inappropriate Assay Range of PCD_M for Recent UF-Control lots |
Fully Automated Urine Particle Digital Imaging Device UD-10 |
IVD7378939616A |
SYSMEX (MALAYSIA) SDN. BHD. |
|
|
10 |
21/07/2026 |
2026-IGT-BST-001 Philips Azurion R2.x.10 systems Potential image quality degradation and potential loss of geometry movement that may lead to delay of therapy, procedural complications, and/or inappropriate treatment. |
AZURION 3 |
GC99381544218 |
PHILIPS MALAYSIA SENDIRIAN BERHAD |
|
|
11 |
21/07/2026 |
2026-IGT-BST-001 Philips Azurion R2.x.10 systems Potential image quality degradation and potential loss of geometry movement that may lead to delay of therapy, procedural complications, and/or inappropriate treatment. |
AZURION 5 |
GC10785320-48186 |
PHILIPS MALAYSIA SENDIRIAN BERHAD |
|
|
12 |
21/07/2026 |
2026-IGT-BST-001 Philips Azurion R2.x.10 systems Potential image quality degradation and potential loss of geometry movement that may lead to delay of therapy, procedural complications, and/or inappropriate treatment. |
AZURION 7 |
GC82521235717 |
PHILIPS MALAYSIA SENDIRIAN BERHAD |
|
|
13 |
21/07/2026 |
2026-IGT-BST-001 Philips Azurion R2.x.10 systems Potential image quality degradation and potential loss of geometry movement that may lead to delay of therapy, procedural complications, and/or inappropriate treatment. 4 |
AZURION BIPLANE |
GC59959884718 |
PHILIPS MALAYSIA SENDIRIAN BERHAD |
|
|
14 |
22/07/2026 |
FA-26022- Beckman Coulter has determined that a modification made by operators to 25 predefined calculated rules, which are included as part of the parameter package, will revert to the default expression following parameter package or software upgrades on the DxC 500i Clinical Analyzer and DxC 500 AU Clinical Chemistry Analyzer |
DxC 500 AU Clinical Chemistry Analyzer |
IVDA3952124-168118 |
BECKMAN COULTER MALAYSIA SDN. BHD. |
|
|
15 |
22/07/2026 |
FA-26022- Beckman Coulter has determined that a modification made by operators to 25 predefined calculated rules, which are included as part of the parameter package, will revert to the default expression following parameter package or software upgrades on the DxC 500i Clinical Analyzer and DxC 500 AU Clinical Chemistry Analyzer. |
DxC 500i AU Chemistry Module |
IVDA8913224-171351 |
BECKMAN COULTER MALAYSIA SDN. BHD. |
|
|
16 |
23/07/2026 |
2025-IGT-BST-014 Philips Azurion R3.1 Systems Potential loss of imaging (X-ray) functionality, and/or loss of motorized movement may result in a delay or termination of procedure |
AZURION BIPLANE |
GC59959884718 |
PHILIPS MALAYSIA SENDIRIAN BERHAD |
|
|
17 |
23/07/2026 |
2025-IGT-BST-014 Philips Azurion R3.1 Systems Potential loss of imaging (X-ray) functionality, and/or loss of motorized movement may result in a delay or termination of procedure |
AZURION 5 |
GC10785320-48186 |
PHILIPS MALAYSIA SENDIRIAN BERHAD |
|
|
18 |
23/07/2026 |
2025-IGT-BST-014 Philips Azurion R3.1 Systems Potential loss of imaging (X-ray) functionality, and/or loss of motorized movement may result in a delay or termination of procedure |
AZURION 7 |
GC82521235717 |
PHILIPS MALAYSIA SENDIRIAN BERHAD |
|
|
19 |
23/07/2026 |
Specific Advice to inform Users, Importers, and Distributors about a discrepancy in the Synthetic Vascular Graft labeling concerning magnetic resonance (MR) compatibility. |
SYNTHETIC VASCULAR GRAFT |
GD9447824-189842 |
B. BRAUN MEDICAL INDUSTRIES SDN. BHD. |
|
|
20 |
23/07/2026 |
Urgent Field Safety Notice for HOMECHOICE AUTOMATED PD SET WITH CASSETTE AND 4-PRONG LUERS due to an increase in reports of alarms such as “Check Lines & Bags” and “Reload the Set 156" occurring during use of the HomeChoice cycler which may prevent the HomeChoice system from initiating the therapy cycle. |
HOMECHOICE AUTOMATED PD SET WITH CASSETTE AND 4-PRONG LUERS |
GB79279741418 |
VANTIVE SDN BHD |
|
|
21 |
30/07/2026 |
044 CN POC 26-008 Epoc Host2 & NXS Host | Positive bias on creatinine and other parameters calculated using creatinine. |
EPOC BLOOD ANALYSIS SYSTEM |
IVDC7557621-75750 |
SIEMENS HEALTHCARE SDN. BHD. |
|
|
22 |
31/07/2026 |
FA-001553- Beckman Coulter has determined that a software defect in AU480 Chemistry Analyzers using Microsoft® SQL Server 2022 Express may cause a DBConnectionError that renders AlarmDB unreadable and prevents instrument startup. The issue is associated with transaction log auto-growth, and may cause delays in reporting patient test results to physicians |
AU 480 Analyzer |
IVDA6207123-155235 |
BECKMAN COULTER 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.
