The list below contains Medical Device’s Field Corrective Action for the month of April 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.

No.

Date Received

Title of FCA

Affected Medical Device

MDA Reference Number

MDA Registration Number

Local Establishment Contact Detail

1.

02/04/2025

 Carestation 620/650/650c and 750/750c Anesthesia Systems– mechanical ventilation not effective in Volume Control Ventilation (VCV) mode

CARESTATION 650 A1, CARESTATION 650C A1, CARESTATION 620 A1

MDA/FCA/P1251-86707162-2025

GC5901122-104148

GE HEALTHCARE SDN. BHD

premarket.my@ge.com

2.

02/04/2025

 Carestation 620/650/650c and 750/750c Anesthesia Systems– mechanical ventilation not effective in Volume Control Ventilation (VCV) mode

CARESTATION 700 SERIES

MDA/FCA/P1252-92049677-2025

GC2333221-51495

3.

03/04/2025

 024 FSCA POC 25-006 Stratus CS cTnI TestPak | False Positive cTnI Results for Acute Care™ cTnI TestPak

STRATUS CS ACUTE CARE TROPONIN I TESTPAK (CCTNI)

MDA/FCA/P1253-92937085-2025

IVDC24726172018

SIEMENS HEALTHCARE SDN. BHD.

aili.siow@siemens-healthineers.com

4.

08/04/2025

 FRED Easyport - Defective IGBT module (SAGQI-1082)

FRED EASYPORT

MDA/FCA/P1254-27269859-2025

GC734506016

SCHILLER ASIA PACIFIC SDN. BHD.

thiamhong.lim@schiller.com.my

5.

08/04/2025

 All current and future lots of HemosIL Fibrinogen-C and Fibrinogen-C XL may have an issue with the labeled stability of the reconstituted frozen product. This affects Part Nos. 0020301100 and 0020003900.

FIBRINOGEN-C ASSAY

MDA/FCA/P1255-65543931-2025

IVDB75891303518

STRAITS SCIENTIFIC (M) SDN BHD

straits@3s.com.my

6.

09/04/2025

 Voluntary product recall for reusable blood pressure cuffs

Welch Allyn 767 Blood Pressure Gauges

MDA/FCA/P1259-76960707-2025

GA2325622-90637

WELCH ALLYN MALAYSIA SDN BHD

jason_lee@baxter.com

7.

09/04/2025

 Voluntary product recall for reusable blood pressure cuffs

Welch Allyn Blood Pressure Gauges

MDA/FCA/P1260-76254211-2025

GA7214422-88069

8.

09/04/2025

 Voluntary product recall for reusable blood pressure cuffs

WELCH ALLYN SPOT VITAL SIGNS 4400

MDA/FCA/P1261-12929252-2025

GB2769120-48200

9.

10/04/2025

 Insufficiencies in Markings and Symbols in the User Manual, Label, and Cuff of the Ouson+ Arm Type Electronic Blood Pressure Monitor BSX523

ARM TYPE ELECTRONIC BLOOD PRESSURE MONITOR

MDA/FCA/P1256-45172325-2025

GB3302221-71460

REANNEQ SDN BHD

vince3carol@gmail.com

10.

10/04/2025

 Insufficiencies in Markings and Symbols in the User Manual, Label, and Cuff of the Ouson+ Infrared Thermometer BSX976

INFRARED THERMOMETER

MDA/FCA/P1258-34098024-2025

GB9625021-73434

11.

10/04/2025

 Powerheart G5 - Alert on Error Code (EC) 501 or other device alert before attempted device use.

POWERHEART G5 AED

MDA/FCA/P1262-78430519-2025

GC3984123-151593

ZOLL MEDICAL MALAYSIA SDN. BHD.

WThor@zoll.com

12.

14/04/2025

 FA-25031 – REMISOL Advance may encounter issues processing orders without a patient Date of Birth.

Remisol Advance

MDA/FCA/P1263-61210361-2025

IVDA1548022-91734

BECKMAN COULTER MALAYSIA SDN. BHD.

song01@beckman.com

13.

16/04/2025

 Potential temperature excursion of Xpert® BCR-ABL Ultra due to storage outside of labeled storage conditions.

XPERT BCR-ABL ULTRA

MDA/FCA/P1265-81822428-2025

IVDC74609321918

SPD SCIENTIFIC (M) SDN. BHD.

zk.hor@spdscientific.com

14.

16/04/2025

 Some breathing tube devices may be hard to disconnect during medical procedures. Updated instructions will be provided to help fix this problem.

INTELLIVUE PATIENT MONITOR MX750 & MX850

MDA/FCA/P1264-49047009-2025

GC2975220-43026

PHILIPS MALAYSIA SDN BERHAD

joshua.chan@philips.com

15.

16/04/2025

 Some CO₂ filter line devices (Microstream Advance, VitaLine, and FilterLine) may be hard or impossible to disconnect from a patient’s breathing tube during procedures.

Microstream™ Advance Adult-Pediatric Intubated CO2 Filter Line

MDA/FCA/P1266-73349698-2025

GA8398123-133429

16.

16/04/2025

 2025-CC-HPM-011 – Difficulty disconnecting certain CO₂ filter line devices from patient breathing tubes during procedures.

Microstream™ Advance Neonatal-Infant Intubated CO2 Filter Line

MDA/FCA/P1267-54431159-2025

GA8287423-132544

17.

16/04/2025

 2025-EI-PCI-001 - IntelliSpace Cardiovascular 6.x, 7.x, and 8.x Report content may be inaccurate when using Finding Codes to add information.

INTELLISPACE CARDIOVASCULAR

MDA/FCA/P1268-79051646-2025

GB83311816318

18.

16/04/2025

 Update on Storage Instructions and Safety Recommendations for ‘Syringe Without Needle’

SYRINGE WITHOUT NEEDLE

MDA/FCA/P1270-27016588-2025

GA8289892816

MUZAMAL INDUSTRIES SDN BHD

m.muza@muzamal.my

19.

16/04/2025

 026 FSCA AIMC 25-06 Atellica IM and ADVIA Centaur Homocysteine Calibrator | Atellica IM and ADVIA Centaur Homocysteine Calibrator Instability

ATELLICA® IM HOMOCYSTEINE (HCY)

MDA/FCA/P1271-41660423-2025

IVDB59216279518

SIEMENS HEALTHCARE SDN. BHD.

aili.siow@siemens-healthineers.com

20.

16/04/2025

 026 FSCA AIMC 25-06 Atellica IM and ADVIA Centaur Homocysteine Calibrator Instability

ADVIA CENTAUR® HCY

MDA/FCA/P1272-71088702-2025

IVDB5671151317

21.

22/04/2025

 Blood Pressure Monitor YE660D with the situation where the information of the Instruction for Use and the cuff is incomplete

YUWELL ELECTRONIC BLOOD PRESSURE MONITOR

MDA/FCA/P1276-30030441-2025

GB6571022-90872

RBD HEALTHCARE SDN BHD

sookpei@rbdhealthcare.com

22.

24/04/2025

 Iron Gen.2: throughput dependent signal drifts on cobas® c 311 and cobas c 501/502

IRON2

MDA/FCA/P1277-63057361-2025

IVDB6137023-142666

ROCHE DIAGNOSTICS (M) SDN. BHD.

chai_yin.heng@roche.com

23.

24/04/2025

 CHA CC and CHA A systems may discontinue 'Continuous' infusion orders once the ordered amount is administered, even if the prescribed time duration has not been reached.

Centricity High Acuity Critical Care

MDA/FCA/P1279-20157066-2025

GA2352020-44975

GE HEALTHCARE SDN. BHD

premarket.my@ge.com

24.

24/04/2025

 CHA CC and CHA A systems The CHA system discontinues infusion orders with a ‘Continuous’ timing schedule once the ordered amount is given even if the prescribed time duration is not met.

CENTRICITY HIGH ACUITY ANESTHESIA

MDA/FCA/P1280-75147006-2025

GMD29146275517A

25.

24/04/2025

 CHA CC and CHA A systems - potential cybersecurity vulnerability within one of the CHA components. Exposure of this potential vulnerability is limited to the local network.

Centricity High Acuity Critical Care

MDA/FCA/P1281-19211452-2025

GA2352020-44975

26.

24/04/2025

 CHA CC and CHA A systems - potential cybersecurity vulnerability within one of the CHA components. Exposure of this potential vulnerability is limited to the local network.

CENTRICITY HIGH ACUITY ANESTHESIA

MDA/FCA/P1282-91662220-2025

GMD29146275517A

27.

25/04/2025

 WELCH ALLYN CONNEX Vital Signs Monitor and 9-Cell Lithium Ion Battery Single Pack - Fire Events Due to Use of Unapproved Batteries

WELCHALLYN VITAL SIGNS MONITOR 6000 SERIES

MDA/FCA/P1283-49893181-2025

GC668071053318

WELCH ALLYN MALAYSIA SDN BHD

jason_lee@baxter.com

28.

25/04/2025

 WELCH ALLYN CP-150 Electrocardiograph - Fire Events Due to Use of Unapproved Batteries

CP150 ELECTROCARDIOGRAPH

MDA/FCA/P1284-82158291-2025

GB426243716

29.

25/04/2025

 WELCH ALLYN CONNEX Accessory Power Management Stand - Fire Events Due to Use of Unapproved Batteries

WELCH ALLYN CONNEX SPOT MONITOR

MDA/FCA/P1285-19643153-2025

GB2941520-49095

30.

28/04/2025

 FCA for ENDOPATH ECHELON™ Vascular White Reload (35 mm, 4 Row) due to inadvertent premature sled movement lockout.

ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP AND ENDOPATH ECHELON VASCULAR WHITE RELOAD FOR ADVANCED PLACEMENT TIP

MDA/FCA/P1286-27738822-2025

GD69385440117

JOHNSON & JOHNSON SDN BHD

DL-JACMYWZ-MEDMY_Regulatory_Affairs@ITS.JNJ.com

31.

28/04/2025

 Mandatory BIOFIRE Blood Culture Identification 2 (BCID2) Panel Pouch Module Software Update

BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL

MDA/FCA/P1287-56624041-2025

IVDB7118221-52555

BIOMERIEUX MALAYSIA SDN BHD

michael.conlon@biomerieux.com

32.

29/04/2025

 FA-001294 – Certain lots of Creatinine reagent (REF OSR6178) do not consistently meet the icteric/bilirubin interference specification for serum/plasma, as outlined in the IFU.

CREATININE

MDA/FCA/P1275-15944645-2025

IVDB9994822-104696

BECKMAN COULTER MALAYSIA SDN. BHD.

song01@beckman.com

33.

29/04/2025

 FA-001346 – MU993400 sample probes (lot numbers 178713114 to 179433670) on AU480 and AU680 analyzers may cause false low test results due to sample dispensing issues

AU 480 Analyzer

MDA/FCA/P1288-23465844-2025

IVDA6207123-155235

34.

29/04/2025

 FA-001353- Incorrect target value of 166 mg/dL for the level 4 calibrator ODR3022, Lot 3000. The correct level 4 target value is 116 mg/dL. The value in g/L unit is correct.

LIPOPROTEINS

MDA/FCA/P1290-93374987-2025

IVDB10951521-80118