Field Safety Corrective Action
Understand the requirements when implementing a Field Safety Corrective Action (FSCA) for medical devices supplied in Singapore.
Last updated 13 March 2026
FSCA refers to any corrective action taken in the field to reduce a risk of serious injury or death. This may include recalls, product modifications, software updates, relabelling, or updated instructions for use.
1. When to report
When medical devices are suspected of being potentially harmful to users, they may be subjected to a Field Safety Corrective Action (FSCA).
2. How to report
Medical device dealers should report the Field Safety Corrective Action via the Online Safety, Compliance Application and Registration (OSCAR) System.
3. Risk management
Dealers need to be clear on what should be done when their medical devices are affected by a FSCA.
4. List of published risk communication
Please click on the following links to view the Field Safety Notices submitted for the FSCAs reported to HSA.