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MEDICAL DEVICE FIELD CORRECTIVE ACTION LISTING AUGUST 2026
The list below contains Medical Device’s Field Corrective Action for the month of August 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 AUGUST 2026
|
No. |
Date Received |
Title of FCA |
Affected Medical Device |
MDA Reference Number |
MDA Registration Number |
Local Establishment Contact Detail |
|
1 |
06/08/2026 |
Electric Shock Incident happened to user when using registered medical device (Hydrafacial Elite- GB3699926-223705) |
HYDRAFACIAL MD ELITE |
MDA/FCA/P1884-34969787-2026 |
GB3699926-223705 |
NEOASIA (M) SDN BHD |
|
2 |
02/08/2026 |
Phase II Auto Suture™ Trocar - Updated IFU Availability |
AUTOSUTURE BLUNT TIP TROCAR |
GB72185514917 |
MEDTRONIC MALAYSIA SDN BHD |
|
|
3 |
04/08/2026 |
2026-CC-HPM-008 - Philips IntelliVue Patient Monitors Continuous Reboot with Active Display |
PHILIPS INTELLIVUE INFORMATION CENTER IX APPLICATION SW |
GC56105716618 |
PHILIPS MALAYSIA SENDIRIAN BERHAD |
|
|
4 |
06/08/2026 |
A review of Na⁺ results from normal patient populations on the GEM Premier 5000 and GEM Premier 7000 systems shows a negative bias relative to the published serum reference range. To optimize alignment with this reference range, Werfen will implement an adjustment to the Na⁺ setting in future PAK lots. This adjustment applies a shift of approximately +3 mM across the Na⁺ analytical measurement range. |
GEM PREMIER 5000 BLOOD GAS SYSTEM |
IVDC33500201118 |
STRAITS SCIENTIFIC (M) SDN BHD |
|
|
5 |
13/08/2026 |
Carescape™ Central Station (CSCS) V3.0.x A software issue may delay patient monitoring for at least 3 minutes after a system restart, potentially delaying detection of significant patient events. CARESCAPE CENTRAL STATION (GC6222122-94374) |
CARESCAPE CENTRAL STATION |
GC6222122-94374 |
GE HEALTHCARE SDN. BHD |
|
|
6 |
13/08/2026 |
Aisys CS2, Aisys CS2 with Et Control and S/5 Aisys Anesthesia Systems automatically transitioning to Alternate O2 control AISYS CS2 (GC59982267817) |
AISYS CS2 |
GC59982267817 |
GE HEALTHCARE SDN. BHD |
|
|
7 |
17/08/2026 |
CENTRICITY PACS (RA1000) |
GB9159425-211220 |
GE HEALTHCARE SDN. BHD |
||
|
8 |
18/08/2026 |
Field Safety Corrective Action (FSCA) / Voluntary Medical Device Correction (Notification) for Automated Impella Controller (AIC) - Correction of the purge pressure sensor assembly within the AIC. |
IMPELLA CP® WITH SMARTASSIST® SET |
GD9474523-140294 |
DCH AURIGA (M) SDN BHD |
|
|
9 |
17/08/2026 |
Potential for Incorrect Patient and Study Association Following Historical Data Migration from a Legacy System to Enterprise Archive with Core Services Hub/ Workflow Core Services or to Centricity PACS or to standalone Enterprise Archive Centricity Enterprise Archive (GA8749724-164527) |
CENTRICITY ENTERPRISE ARCHIVE |
GA8749724-164527 |
GE HEALTHCARE SDN. BHD |
|
|
10 |
17/08/2026 |
APM-26-06129 ForeSightTM Oximeter Cable Labels Switched (Affected model number: HEMFSM10) |
HEMOSPHERE ADVANCED MONITORING PLATFORM |
GC766371236819 |
EDWARDS LIFESCIENCES (MALAYSIA) SDN BHD |
|
|
11 |
17/08/2026 |
APM-26-06129 ForeSightTM Oximeter Cable Labels Switched (Affected model number: HEMFSM10) |
HEMOSPHERE ALTA ADVANCED MONITORING PLATFORM |
GC8808625-209005 |
EDWARDS LIFESCIENCES (MALAYSIA) SDN BHD |
|
|
12 |
18/08/2026 |
FA-26031- Beckman Coulter received customer complaints of lamina fluid leaks in iQ200 Series and DxU 840m/850m Analyzers. |
IQ200 SERIES URINE MICROSCOPY SYSTEM (INTERNATIONAL) |
IVDB5900924-166640 |
BECKMAN COULTER MALAYSIA SDN. BHD. |
|
|
13 |
19/08/2026 |
045 FSCA ACHC 26-10 Atellica CH Revised C-Reactive Protein (RCRP) | Potential for Falsely Elevated or Flagged Results When Using the Atellica CH Revised C-Reactive Protein (RCRP) Assay |
ATELLICA® CH REVISED C REACTIVE PROTEIN (RCRP) |
IVDB10942623-142160 |
SIEMENS HEALTHCARE SDN. BHD. |
|
|
14 |
24/08/2026 |
FILMARRAY PNEUMONIA PANEL PLUS |
IVDC3485124-165919 |
BIOMERIEUX MALAYSIA SDN BHD |
||
|
15 |
24/08/2026 |
MEDICAL DEVICE CORRECTION Hemospray Endoscopic Hemostat |
HEMOSTASIS DEVICES |
GB8677723-144784 |
COOK ASIA (MALAYSIA) SDN BHD |
|
|
16 |
27/08/2026 |
2026-PD-CTAMI-003 Spectral CT with software version V5.0, V5.2, or V5.4 Image artifacts, wrong slice thickness, unintended motion |
SPECTRAL CT |
GC6307722-96412 |
PHILIPS MALAYSIA SENDIRIAN BERHAD |
|
|
17 |
27/08/2026 |
DRAEGER HEATED BREATHING CIRCUIT |
GB10569223-152691 |
DRAEGER MALAYSIA SDN BHD |
||
|
18 |
27/08/2026 |
2026-CC-HPM-010 - Philips IntelliVue Patient Monitors Continuous Reboot with Active Display |
INTELLIVUE PATIENT MONITOR MX750 & MX850 |
GC2975220-43026 |
PHILIPS MALAYSIA SENDIRIAN BERHAD |
|
|
19 |
28/08/2026 |
D-100 HEMOGLOBIN TESTING SYSTEM |
MDA/FCA/P1914-18941550-2026 |
IVDB4821967817 |
CHEMOPHARM 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.
