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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 |
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 APHERESIS SYSTEM |
MDA/FCA/P0831-87362417-2024 |
GC321895716 |
TERUMO MALAYSIA SDN. BHD HILMY BIN YEOP AHMAD |
|
|
3 |
05/06/2024 |
pdf Wired Avalon Ultrasound Transducer - (580 KB) pdf Inaccurate Fetal Heart Rate (FHR) measurements when monitoring multiples (580 KB)
|
AVALON FETAL MONITORS |
MDA/FCA/P0832-29827632-2024 |
GC95268545118 |
PHILIPS MALAYSIA SDN BERHAD CHAN JIN HOE |
|
4 |
05/06/2024 |
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 |
MDA/FCA/P0837-15164984-2024 |
IVDD3300676017 |
BECKMAN COULTER MALAYSIA SDN. BHD. ONG NGUAN CHING |
|
|
6 |
10/06/2024 |
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 |
MDA/FCA/P0846-70119633-2024 |
IVDC7183621-56115 |
ROCHE DIAGNOSTICS (M) SDN. BHD. HENG CHAI YIN |
|
|
8 |
11/06/2024 |
pdf Cracks Developing in Pump Housing of Afinion 2 Instrument (249 KB) |
AFINION 2 |
MDA/FCA/P0826-23942254-2024 |
IVD27240868318A |
ABBOTT DIAGNOSTICS HEALTH SDN BHD Wong Mun Hong |
|
9 |
11/06/2024 |
MEDICAL VENTILATOR |
MDA/FCA/P0825-19855036-2024 |
GC25545945118 |
STAR MEDIK SDN. BHD. TAJUDDIN BIN ABDUL LATIF |
|
|
10 |
12/06/2024 |
pdf SENSE XL Torso -All Serial Numbers for Specific Models (929 KB) pdf Potential for patients to sustain burns resulting from heated coil (929 KB)
|
INGENIA 1.5T, INGENIA 3.0T |
MDA/FCA/P0852-99793619-2024 |
GB63162332517 |
PHILIPS MALAYSIA SDN. BHD. CHAN JIN HOE |
|
11 |
13/06/2024 |
pdf Ultrasound Gel suspected to be contaminated with Burkholderia Cepacia Complex (1.08 MB) |
TRANSMISSION GEL |
MDA/FCA/PX0815-94044524-2024 |
GA13780404317 |
MYMEDIC INNOVATION SDN. BHD. ABD JAFAR BIN ABD GHANI |
|
12 |
13/06/2024 |
pdf RAPIDLab 348EX - Gas Cartridges Not installing Due to Defective Threading (241 KB) |
RAPIDLAB 348 SYSTEMS |
MDA/FCA/P0806-97947255-2024 |
IVDC55146211318 |
SIEMENS HEALTHCARE SDN. BHD. FRAZER RODERICK JOHN |
|
13 |
14/06/2024 |
SIGNA PET/MR |
MDA/FCA/P0853-42126652-2024 |
GB5462323-116496 |
GE HEALTHCARE SDN. BHD. LIM SOCK SIANG |
|
|
14 |
14/06/2024 |
pdf Atellica IM and ADVIA Centaur Red Blood Cell (RBC) Folate (Fol) Invalid Calibration (283 KB) |
ATELLICA® IM FOLATE (FOL) |
MDA/FCA/P0855-23870360-2024 |
IVDB12482267618 |
SIEMENS HEALTHCARE SDN. BHD. FRAZER RODERICK JOHN |
|
15 |
18/06/2024 |
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 |
MDA/FCA/P0858-49294013-2024 |
GC5599621-63426 |
OLYMPUS (MALAYSIA) SDN. BHD. HIDEKI NAGAI |
|
|
17 |
19/06/2024 |
pdf Suction Liner 2.0L with Safety Filter Valve with potential burst risk (344 KB) |
SUCTION LINER SYSTEM |
MDA/FCA/P0836-11454991-2024 |
GB2951123-123965 |
MYMEDIC INNOVATION SDN. BHD. ABD JAFAR BIN ABD GHANI |
|
18 |
20/06/2024 |
BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL |
MDA/FCA/P0859-29144399-2024 |
IVDB7118221-52555 |
BIOMERIEUX MALAYSIA SDN. BHD. MICHAEL CONLON |
|
|
19 |
21/06/2024 |
pdf Access 2 Immunoassay system (450 KB) pdf an increased amount of reagent carousel motion errors (450 KB)
|
ACCESS ULTRASENSITIVE HGH |
MDA/FCA/P0864-11698907-2024 |
IVDB10306623-125414 |
BECKMAN COULTER MALAYSIA SDN. BHD. ONG NGUAN CHING |
|
21 |
24/06/2024 |
pdf Ear Thermometer – Incorrect Version of IFU Packaged with Devices (219 KB) |
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 |
MDA/FCA/P0870-44163701-2024 |
GB5890720-48798 |
MEDTRONIC MALAYSIA SDN. BHD. YAM KIN HUNG |
