MEDICAL DEVICE FIELD CORRECTIVE ACTION LISTING AUGUST 2025
The list below contains Medical Device’s Field Corrective Action for the month of August 2025. 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 AUGUST 2025
|
No. |
Date Received |
Title of FCA |
Affected Medical Device |
MDA Reference Number |
MDA Registration Number |
Local Establishment Contact Detail |
|
1. |
21/08/2025 |
Catheter Foley 2 Way Balloon with potential for water in the catheter balloon not being able to be removed and catheter balloon not being able to deflate |
CATHETER FOLEY 2 WAY BALLOON |
GB36726735318 |
MYMEDIC INNOVATION SDN BHD |
|
|
2. |
14/08/2025 |
Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) System Over Temperature Field Action |
CARDIOSAVE INTRA-AORTIC BALLOON PUMP |
GC2992923-137663 |
RBD HEALTHCARE SDN BHD |
|
|
3. |
07/08/2025 |
036 FSCA ACHC 24-07 2nd Follow Up Atellica CH Revised C Reactive Protein (RCRP) | Incorrect Software Flagging for the Atellica CH Revised C Reactive Protein (RCRP) Assay |
ATELLICA® CH REVISED C‑REACTIVE PROTEIN (RCRP) |
IVDB10942623-142160 |
SIEMENS HEALTHCARE SDN. BHD. |
|
|
4. |
07/08/2025 |
037 CN POC 25-015 Chek Stix Liquid QC Kit | Foreign Material Identified in Quality Control Product |
AUTOMATED URINE CHEMISTRY ANALYZER |
IVDB36827210418 |
SIEMENS HEALTHCARE SDN. BHD. [email protected] |
|
|
5. |
08/08/2025 |
Field Safety Notice Urgent Medical Device Correction – Potential for Loose Universal Surgical Manipulators on da Vinci X and Xi Systems (ISIFA2022-14-C) |
DA VINCI XI SURGICAL SYSTEM, ENDOSCOPIC INSTRUMENT CONTROL SYSTEM, MODEL IS4000 |
GC3810021-64842 |
DTG MEDICAL SDN BHD |
|
|
6. |
11/08/2025 |
VITROS® Chemistry Products Ca Slides, Generations 67 and Above, May Experience Increased Incidence of Calibration Failures |
VITROS CHEMISTRY PRODUCTS ELECTROLYTES REAGENTS |
IVDB7599223-142604 |
T T MEDICAL MANAGEMENT SDN BHD |
|
|
7. |
13/08/2025 |
MR040/25/S (CSAN), MR042/25/S - Inspection of Magnet Venting System |
MAGNETOM SKYRA |
GB44064488717 |
SIEMENS HEALTHCARE SDN. BHD. |
|
|
8. |
13/08/2025 |
MR040/25/S (CSAN), MR042/25/S - Inspection of Magnet Venting System |
MAGNETOM PRISMA |
GB75698797118 |
SIEMENS HEALTHCARE SDN. BHD. |
|
|
9. |
13/08/2025 |
MR040/25/S (CSAN), MR042/25/S - Inspection of Magnet Venting System |
MAGNETOM VIDA |
GB75575532218 |
SIEMENS HEALTHCARE SDN. BHD. |
|
|
10. |
13/08/2025 |
MR040/25/S (CSAN), MR042/25/S - Inspection of Magnet Venting System |
MAGNETOM LUMINA |
GB3902419-30683 |
SIEMENS HEALTHCARE SDN. BHD. |
|
|
11. |
13/08/2025 |
FA-25056- on the DxC 500i Clinical Analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed between the CC constituent tests, the sample status of the CC test will remain “In Progress” with no error events. |
DxC 500i AU Chemistry Module |
IVDA8913224-171351 |
BECKMAN COULTER MALAYSIA SDN. BHD. |
|
|
12. |
14/08/2025 |
MR041/25/S (CSAN), MR042/25/S - Inspection of Magnet Venting System |
MAGNETOM SPECTRA |
GB64827212817 |
SIEMENS HEALTHCARE SDN. BHD |
|
|
13. |
14/08/2025 |
038 FSCA ACHC 25-07 Atellica CH Urinary Cerebrospinal Fluid Protein (UCFP) | Falsely Depressed Results for the Atellica CH UCFP Assay. May Act as a Heat Source with Potential to Produce Smoke and/or Fire. |
ATELLICA® CH URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) |
IVDB5927720-49887 |
SIEMENS HEALTHCARE SDN. BHD. |
|
|
14. |
18/08/2025 |
The two housings of Various Clear-Therm Mini HMEF devices separate when a force is applied during handling |
BREATHING FILTERS, HMES AND HMEFS |
MDA/FCA/P1386-20871349-2025 |
GB890231283619 |
INTERSURGICAL SDN BHD |
|
15. |
18/08/2025 |
Updating product-specific Instructions for Use (IFU) for Skull Traction Tong Large |
AESCULAP SURGICAL INSTRUMENT NEUROSURGERY |
GD17535444617 |
B. BRAUN MEDICAL INDUSTRIES SDN. BHD. |
|
|
16. |
18/08/2025 |
Urgent Medical Device Correction for the PrisMax Systems and TherMax Blood Warmer Units on PrisMax System alarm T2309, PrisMax System alarm T0830 and Thermax System may be unable to detect the presence of a bag on the Thermax Blood Warmer Unit leading to difficulty setting up therapy, or PrisMax System alarm T2284 |
PRISMAX |
GC9127823-124035 |
VANTIVE SDN BHD |
|
|
17. |
20/08/2025 |
NOTIFICATION ON POTENTIAL WEAK IMMUNOHISTOCHEMISTRY STAINING WITH FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis), GA604 |
DAKO OMNIS (ATSI)-LYMPHATIC TISSUE AND BONE MARROW |
IVDC7441223-151113 |
BITA LIFESCIENCE SDN. BHD. |
|
|
18. |
25/08/2025 |
FA-AM-FEB2025-305: Alinity M Software Update 1.9.0 |
ALINITY M SYSTEM |
IVDB7120020-41682 |
ABBOTT LABORATORIES (MALAYSIA) SDN. BHD. |
|
|
19. |
25/08/2025 |
Urgent on replace of HU 35 Tank Fittings |
HEATER UNIT HU35 |
GC6292720-45160 |
RBD HEALTHCARE SDN BHD |
|
|
20. |
26/08/2025 |
039 FSCA ACHC 25-07 Follow Up Atellica CH Urinary Cerebrospinal Fluid Protein (UCFP) | Potential for Falsely Depressed Results with the Atellica CH UCFP Assay |
ATELLICA® CH URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) |
IVDB5927720-49887 |
SIEMENS HEALTHCARE 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.
