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FIELD CORRECTIVE ACTION LISTING FOR OCTOBER 2024
The list below contains Medical Device’s Field Corrective Action for the month of October 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 |
04/10/2024 |
ACCESS CORTISOL |
MDA/FCA/P1009-13638506-2024 |
IVDB2237522-98057 |
BECKMAN COULTER MALAYSIA SDN. BHD. |
|
|
2 |
08/10/2024 |
ATELLICA IM ERYTHROPOIETIN (EPO) |
MDA/FCA/P1014-93545672-2024 |
IVDB5198820-45185 |
SIEMENS HEALTHCARE SDN. BHD |
|
|
3 |
09/10/2024 |
pdf Loose Power Inlet Connections on BKActiv 2300 Ultrasound Devices with Battery Option (124 KB) |
BK MEDICAL BK2300 ULTRASOUND SCANNER SYSTEM |
MDA/FCA/P0989-18030660-2024 |
GD69454346817 |
MEDI-LIFE (M) SDN. BHD. |
|
4 |
10/10/2024 |
UROPASS URETERAL ACCESS SHEATH SET |
MDA/FCA/P1016-73629562-2024 |
GB32940617118 |
OLYMPUS (MALAYSIA) SDN. BHD. |
|
|
5 |
10/10/2024 |
pdf Centricity Universal Viewer Zero Footprint Client– Potential Security Vulnerability (345 KB) |
CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT |
MDA/FCA/P1017-22045514-2024 |
GB7561822-102555 |
GE HEALTHCARE SDN. BHD |
|
6 |
10/10/2024 |
RAPIDPOINT 500 |
MDA/FCA/P1018-19659929-2024 |
IVDC6984796818 |
SIEMENS HEALTHCARE SDN. BHD. |
|
|
7 |
11/10/2024 |
ZENITION 50 |
MDA/FCA/P1019-58353164-2024 |
GC2933619-31252 |
PHILIPS MALAYSIA SDN BERHAD |
|
|
8 |
11/010/2024 |
ZENITION 70 |
MDA/FCA/P1020-90809242-2024 |
GC2523519-30212 |
PHILIPS MALAYSIA SDN BERHAD |
|
|
9 |
16/10/2024 |
pdf Revised Reprocessing Instructions for Olympus GIF-1TH190 Gastrointestinal Videoscope (1.73 MB) |
EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE SYSTEM |
MDA/FCA/P1024-34515947-2024 |
GB41963114717 |
OLYMPUS (MALAYSIA) SDN. BHD. |
|
10 |
17/10/2024 |
TruSystem 7000 Surgical table, universal |
MDA/FCA/P1026-66662818-2024 |
GA10975523-128720 |
WELCH ALLYN MALAYSIA SDN BHD |
|
|
11 |
22/10/2024 |
Z-HYALIN PLUS |
MDA/FCA/P1033-60566131-2024 |
GC861937216 |
CARL ZEISS SDN BHD |
|
|
12 |
22/10/2023 |
pdf Trilogy EV300 Flow Sensor Nebulized Aerosol Deposition (378 KB) |
TRILOGY EV300 |
MDA/FCA/P1036-30879259-2024 |
GC5498920-50666 |
PHILIPS MALAYSIA SDN BERHAD |
|
14 |
23/10/2024 |
ATELLICA CH 930 ANALYZER |
MDA/FCA/P1037-63055306-2024 |
IVD34641418218A |
SIEMENS HEALTHCARE SDN. BHD. |
|
|
15 |
24/10/2024 |
pdf Atellica IM Folate (Fol) Invalid Calibration for Whole Blood Sample Type (250 KB) s |
ATELLICA® IM FOLATE (FOL) |
MDA/FCA/P1038-92406184-2024 |
IVDB12482267618 |
SIEMENS HEALTHCARE SDN. BHD. |
|
16 |
24/10/2024 |
pdf Vue PACS – Potential for misdiagnosis due to incorrect ischemic map and tables values (468 KB) |
PHILIPS VUE PACS |
MDA/FCA/P1039-67076394-2024 |
GB18651834218 |
PHILIPS MALAYSIA SDN BERHAD |
