FIELD CORRECTIVE ACTION LISTING FOR JUNE 2024
The list below contains Medical Device’s Field Corrective Action for the month of June 2024. 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 |
05/06/2024 |
Update of the Operator’s Guide and Quick Reference Guide for the ZOLL MRI-Compatible Ventilator |
ZOLL 731 SERIES VENTILATOR |
MDA/FCA/P0829-98314323-2024 |
GC6456022-110339 |
ZOLL MEDICAL MALAYSIA SDN. BHD. WENNISA THOR HOOI HSIEN |
|
2 |
05/06/2024 |
Spectra Optia Blood Warmer Not Prime |
SPECTRA OPTIA APHERESIS SYSTEM |
MDA/FCA/P0831-87362417-2024 |
GC321895716 |
TERUMO MALAYSIA SDN. BHD HILMY BIN YEOP AHMAD |
|
3 |
05/06/2024 |
Wired Avalon Ultrasound Transducer - Inaccurate Fetal Heart Rate (FHR) measurements when monitoring multiples |
AVALON FETAL MONITORS |
MDA/FCA/P0832-29827632-2024 |
GC95268545118 |
PHILIPS MALAYSIA SDN BERHAD CHAN JIN HOE |
|
4 |
05/06/2024 |
Atellica CH Iron3 (Iron3) Impacting Atellica CH Cholesterol_2 (Chol_2), Atellica CH LDL Cholesterol (LDLC), and Atellica CH Triglycerides_2 (Trig_2) Results |
ATELLICA® CH IRON3 (IRON3) |
MDA/FCA/P0833-73307176-2024 |
IVDB3863223-114647 |
SIEMENS HEALTHCARE SDN. BHD. FRAZER RODERICK JOHN |
|
5 |
07/06/2024 |
Access HBc Ab Reagent may contain an unusual amount of paramagnetic particle (PMP) that could interfere result. |
ACCESS HBC AB |
MDA/FCA/P0837-15164984-2024 |
IVDD3300676017 |
BECKMAN COULTER MALAYSIA SDN. BHD. ONG NGUAN CHING |
|
6 |
10/06/2024 |
Correction of software faults |
DEFIGARD HD-7 DEFIBRILLATOR WITH MONITOR |
MDA/FCA/P0843-16159574-2024 |
GC6455120-44834 |
SCHILLER ASIA PACIFIC SDN. BHD. LIM THIAM HONG |
|
7 |
11/06/2024 |
Cobas® EGFR Mutation Test v2: Potential for False Mutation Detected results for exon20 Insertion |
COBAS EGFR MUTATION TEST V2 |
MDA/FCA/P0846-70119633-2024 |
IVDC7183621-56115 |
ROCHE DIAGNOSTICS (M) SDN. BHD. HENG CHAI YIN |
|
8 |
11/06/2024 |
Cracks Developing in Pump Housing of Afinion 2 Instrument |
AFINION 2 |
MDA/FCA/P0826-23942254-2024 |
IVD27240868318A |
ABBOTT DIAGNOSTICS HEALTH SDN BHD Wong Mun Hong |
|
9 |
11/06/2024 |
HAMILTON-C6 update software version 1.2.3 |
MEDICAL VENTILATOR |
MDA/FCA/P0825-19855036-2024 |
GC25545945118 |
STAR MEDIK SDN. BHD. TAJUDDIN BIN ABDUL LATIF |
|
10 |
12/06/2024 |
SENSE XL Torso -All Serial Numbers for Specific Models Potential for patients to sustain burns resulting from heated coil |
INGENIA 1.5T, INGENIA 3.0T |
MDA/FCA/P0852-99793619-2024 |
GB63162332517 |
PHILIPS MALAYSIA SDN. BHD. CHAN JIN HOE |
|
11 |
13/06/2024 |
Ultrasound Gel suspected to be contaminated with Burkholderia Cepacia Complex |
TRANSMISSION GEL |
MDA/FCA/PX0815-94044524-2024 |
GA13780404317 |
MYMEDIC INNOVATION SDN. BHD. ABD JAFAR BIN ABD GHANI |
|
12 |
13/06/2024 |
RAPIDLab 348EX - Gas Cartridges Not installing Due to Defective Threading |
RAPIDLAB 348 SYSTEMS |
MDA/FCA/P0806-97947255-2024 |
IVDC55146211318 |
SIEMENS HEALTHCARE SDN. BHD. FRAZER RODERICK JOHN |
|
13 |
14/06/2024 |
B1+RMS predicted value may exceed user prescribed limit in Low SAR Mode for certain MR systems |
SIGNA PET/MR |
MDA/FCA/P0853-42126652-2024 |
GB5462323-116496 |
GE HEALTHCARE SDN. BHD. LIM SOCK SIANG |
|
14 |
14/06/2024 |
Atellica IM and ADVIA Centaur Red Blood Cell (RBC) Folate (Fol) Invalid Calibration |
ATELLICA® IM FOLATE (FOL) |
MDA/FCA/P0855-23870360-2024 |
IVDB12482267618 |
SIEMENS HEALTHCARE SDN. BHD. FRAZER RODERICK JOHN |
|
15 |
18/06/2024 |
Alinity HQ Analyzer Product Correction |
ALINITY HQ ANALYZER |
MDA/FCA/P0857-53882019-2024 |
IVDB31515121518 |
ABBOTT LABORATORIES (MALAYSIA) SDN. BHD. KWA KHENG HOE |
|
16 |
18/06/2024 |
Electrosurgical Generator Esg-410-Replacing the Current Power Supply with a New Power Supply |
ELECTROSURGICAL GENERATOR ESG-410 |
MDA/FCA/P0858-49294013-2024 |
GC5599621-63426 |
OLYMPUS (MALAYSIA) SDN. BHD. HIDEKI NAGAI |
|
17 |
19/06/2024 |
Suction Liner 2.0L with Safety Filter Valve with potential burst risk |
SUCTION LINER SYSTEM |
MDA/FCA/P0836-11454991-2024 |
GB2951123-123965 |
MYMEDIC INNOVATION SDN. BHD. ABD JAFAR BIN ABD GHANI |
|
18 |
20/06/2024 |
False positive Serratia marcescens results on the BIOFIRE BCID2 Panel when used in conjunction with specific lots of BACT/ALERT® Culture Bottles |
BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL |
MDA/FCA/P0859-29144399-2024 |
IVDB7118221-52555 |
BIOMERIEUX MALAYSIA SDN. BHD. MICHAEL CONLON |
|
19 |
21/06/2024 |
Access 2 Immunoassay system an increased amount of reagent carousel motion errors |
ACCESS ULTRASENSITIVE HGH |
MDA/FCA/P0864-11698907-2024 |
IVDB10306623-125414 |
BECKMAN COULTER MALAYSIA SDN. BHD. ONG NGUAN CHING |
|
21 |
24/06/2024 |
Ear Thermometer – Incorrect Version of IFU Packaged with Devices |
WELCH ALLYN BRAUN THERMOSCAN EAR THERMOMETER PRO6000 |
MDA/FCA/P0866-53838178-2024 |
GB57417827518 |
WELCH ALLYN MALAYSIA SDN. BHD. JASON LEE CHIA YII |
|
21 |
26/06/2024 |
NIM Vital System False Negative Responses |
NIM VITAL SYSTEM |
MDA/FCA/P0870-44163701-2024 |
GB5890720-48798 |
MEDTRONIC MALAYSIA SDN. BHD. YAM KIN HUNG |
