FSCAs & Recalls
TR-006 · Field Safety Corrective Actions
An FSCA is any corrective or preventive action taken to reduce, eliminate, or mitigate a risk associated with an already-marketed device. FSCAs are typically initiated when the manufacturer or LRP identifies a previously unknown safety issue, a newly emerging risk, or information suggesting that the device may not perform as originally claimed or intended.
Types of FSCA
| Type | Description |
|---|---|
| Device recall | Return of affected devices |
| Device modification | Upgrade or adjustment to resolve safety issue |
| Labelling correction | Relabelling to address safety-critical errors |
| User notification | Safety information distributed without device return |
Field Safety Notices (FSNs)
An FSCA is communicated to users through a Field Safety Notice (FSN) — a written communication advising healthcare facilities of the problem, the risk, and the action required.
LRP FSCA Obligations
- Notify MDD before or simultaneously with notifying users
- Provide copy of FSN to MDD
- Maintain records of all affected devices and FSNs distributed
- Confirm FSCA completion to MDD