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FIELD CORRECTIVE ACTION LISTING FOR SEPTEMBER 2024
The list below contains Medical Device’s Field Corrective Action for the month of September 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 |
03/09/2024 |
ICHEM VELOCITY URINE CHEMISTRY SYSTEM |
MDA/FCA/P0970-10770217-2024 |
IVDB2172623-115162 |
BECKMAN COULTER MALAYSIA SDN. BHD. |
|
|
2 |
04/09/2024 |
INFUSION SYRINGE PUMP |
MDA/FCA/P0973-78893875-2024 |
GC5420023-141022 |
B. BRAUN MEDICAL INDUSTRIES SDN. BHD. |
|
|
3 |
05/09/2024 |
pdf Automated Compounding Device Inlets – Visible Particulate Matter (531 KB) |
BAXTER EXACTAMIX INLET |
MDA/FCA/P0974-80958566-2024 |
GA9378419-30261 |
BAXTER HEALTHCARE (MALAYSIA) SDN. BHD. |
|
4 |
08/09/2024 |
DIASAFE (Malaysia market only) |
MDA/FCA/P0971-13841856-2024 |
GC78752383817 |
FRESENIUS MEDICAL CARE MALAYSIA SDN BHD |
|
|
5 |
09/09/2024 |
CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT |
MDA/FCA/P0977-21321218-2024 |
GB7561822-102555 |
GE HEALTHCARE SDN. BHD |
|
|
6 |
09/09/2024 |
pdf Atellica IM Interleukin-6 (IL6) Not Meeting Calibration Interval (222 KB) |
ATELLICA IM INTERLEUKIN-6 (IL6) |
MDA/FCA/P0978-30550958-2024 |
IVDB7674621-52295 |
SIEMENS HEALTHCARE SDN. BHD. |
|
8 |
17/09/2024 |
pdf Glove defect detected in latex powdered surgical glove (156 KB) |
LATEX POWDERED SURGICAL GLOVE |
MDA/FCA/PX0984-92367589-2024 |
GB10383723-133684 |
EMERALD GLOVE MANUFACTURING SDN. BHD. |
|
9 |
18/09/2024 |
DXH 500 SYSTEM |
MDA/FCA/P0990-44347536-2024 |
IVDB95852125818 |
BECKMAN COULTER MALAYSIA SDN. BHD. |
|
|
10 |
18/09/2024 |
pdf Certain Giraffe OmniBed and Giraffe OmniBed Carestation – Heater Door Failure (1.19 MB) |
GIRAFFE OMNIBED CARESTATION CS1 |
MDA/FCA/P0991-73772267-2024 |
GC36600486117 |
GE HEALTHCARE SDN. BHD |
|
11 |
19/9/2024 |
pdf Incorrect color correction data Olympus Bronchovideoscope (Model: BF-H1100) (1.23 MB) |
BRONCHOVIDEOSCOPE |
MDA/FCA/P0997-88589076-2024 |
GB4610624-167220 |
OLYMPUS (MALAYSIA) SDN. BHD. |
|
12 |
20/09/2024 |
Potential risk of ceiling collision (Please request FSN if necessary) |
LUMINOS AGILE MAX |
MDA/FCA/P0254-47941047-2023 |
GC74703683318 |
SIEMENS HEALTHCARE SDN BHD |
|
13 |
20/09/2023 |
pdf False Positive Results for Leukocyte Presence on UroColor 10 and UroColor 11 (551 KB) |
URINE STRIPS AND ANALYSER |
MDA/FCA/P0995-37481365-2024 |
IVDB72902332418 |
ABBOTT DIAGNOSTICS HEALTH SDN BHD |
|
14 |
24/09/2024 |
pdf Intermittent loss of function of the OFP-2 Flushing Pump (1.20 MB) |
OLYMPUS FLUSHING PUMP OFP-2 |
MDA/FCA/P0998-46593517-2024 |
GB95384735118 |
OLYMPUS (MALAYSIA) SDN. BHD. |
