fas fa-search
FIELD CORRECTIVE ACTION LISTING FOR DECEMBER 2024
The list below contains Medical Device’s Field Corrective Action for the month of December 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 |
02/12/2024 |
pdf Urine/CSF Albumin REF B46435, Lot 2217 R2 vial underfill. |
URINE / CSF ALBUMIN |
MDA/FCA/P1089-78181333-2024 |
IVDB7476440117 |
BECKMAN COULTER MALAYSIA SDN. BHD. |
|
2 |
05/12/2024 |
pdf CADD-Solis™ Ambulatory Infusion Pumps with Multiple Problems. |
CADD SOLIS AMBULATORY INFUSION PUMP |
MDA/FCA/P1088-74104216-2024 |
GC5586521-80774 |
PRIMED MEDICAL SDN BHD |
|
3 |
09/12/2024 |
pdf Potential Performance Issue with The Aliniq AMS Software Version 3.02 |
AlinIQ AMS |
MDA/FCA/P1092-71063646-2024 |
IVDA6354824-187182 |
ABBOTT LABORATORIES (MALAYSIA) SDN. BHD. |
|
4 |
09/12/2024 |
pdf Mobile X-Ray Column Assembly Issue on Certain Optima XR200/220/240amx Systems |
OPTIMA XR240AMX |
MDA/FCA/P1094-46564621-2024 |
GC9459623-144049 |
GE HEALTHCARE SDN. BHD |
|
5 |
10/12/2024 |
FACSLYRIC CLINICAL SYSTEM |
MDA/FCA/P1093-24290331-2024 |
IVDB4800920-44397 |
BECTON DICKINSON SDN BHD |
|
|
6 |
12/12/2024 |
THORAFLEX HYBRID DEVICE |
MDA/FCA/P1098-47652201-2024 |
GD79535860718 |
TERUMO MALAYSIA SDN. BHD. |
|
|
7 |
13/12/2024 |
pdf Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting. |
TEC 8X0 VAPORIZER (TEC 850, TEC820) |
MDA/FCA/P1099-26686580-2024 |
GC5976322-106915 |
GE HEALTHCARE SDN. BHD |
|
8 |
16/12/2024 |
pdf Idylla™ Instrument Potential of False Positive Results for Idylla™ MSI Test |
IDYLLA™ SYSTEM - IDYLLA™ CONSOLE AND IDYLLA™ INSTRUMENT, IDYLLA™ MSI TEST |
MDA/FCA/P1102-43459295-2024 |
IVDC1207720-43097 |
ANDAMAN MEDICAL BRIDGE SDN. BHD. |
|
9 |
17/12/2024 |
MEDRAD CENTARGO CT INJECTION SYSTEM |
MDA/FCA/P1105-44386650-2024 |
GC2773021-59690 |
BAYER CO.(MALAYSIA)SDN.BHD. |
|
|
10 |
18/12/2024 |
ROTEM® SIGMA |
MDA/FCA/P1103-90080351-2024 |
IVDC3174420-50832 |
STRAITS SCIENTIFIC (M) SDN BHD |
|
|
11 |
18/12/2024 |
SURGICAL TISSUE MANAGEMENT SYSTEM |
MDA/FCA/P1106-50178129-2024 |
GC57003616918 |
OLYMPUS (MALAYSIA) SDN. BHD. |
|
|
12 |
18/12/2024 |
INFINITY CENTRAL STATION WIDE |
MDA/FCA/P1108-31087975-2024 |
GC88553130217 |
DRAEGER MALAYSIA SDN BHD |
|
|
13 |
19/12/2024 |
CYBERKNIFE SYSTEM |
MDA/FCA/P1025-83035699-2024 |
GC39420450717 |
TRANSMEDIC HEALTHCARE SDN BHD |
|
|
14 |
19/12/2024 |
VISERA ELITE SYSTEM |
MDA/FCA/P1107-54356919-2024 |
GB3798579516 |
OLYMPUS (MALAYSIA) SDN. BHD. |
|
|
15 |
19/12/2024 |
pdf Philips MR system breast coils Potential for harm while using a breast coil |
INGENIA ELITION |
MDA/FCA/P1110-38374158-2024 |
GB179941251719 |
PHILIPS MALAYSIA SDN BERHAD |
|
16 |
19/12/2024 |
INGENIA 1.5T, INGENIA 3.0T |
MDA/FCA/P1111-86559761-2024 |
GB63162332517 |
PHILIPS MALAYSIA SDN BERHAD |
|
|
17 |
23/12/2024 |
VITROS CHEMISTRY PRODUCTS DIGOXIN (DGXN) |
MDA/FCA/P1112-59686067-2024 |
IVDC3313423-136491 |
T T MEDICAL MANAGEMENT SDN BHD |
|
|
18 |
24/12/2024 |
SPECTRAL CT |
MDA/FCA/P1118-60320565-2024 |
GC6307722-96412 |
PHILIPS MALAYSIA SDN BERHAD |
|
|
19 |
26/12/2024 |
HEMOSIL LIQUID ANTI-XA |
MDA/FCA/P1116-38756525-2024 |
IVDC53329234618 |
STRAITS SCIENTIFIC (M) SDN BHD |
