FIELD CORRECTIVE ACTION LISTING FOR MAY 2025

The list below contains Medical Device’s Field Corrective Action for the month of May 2025. 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.