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類別: SAFETY SURVEILLANCE
現場安全糾正措施(FSCA)
製造商為降低與已上市器材相關的死亡或健康嚴重惡化風險而採取的行動。FSCA包括器材召回、修改、使用建議和軟體更新。
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.
WHEN IT APPLIES
A Field Safety Corrective Action reduces risk for devices already on the market—recalls, software patches, advice to users—often paired with Field Safety Notices in the EU.
PROCESS / STEPS
- Assess risk and decide action type.
- Notify authorities/NB as required; communicate to customers.
- Implement corrections; verify effectiveness.
- Update PMS/risk documentation.
EXAMPLES
- A cybersecurity patch distributed as FSCA with user instructions.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to 現場安全糾正措施(FSCA) across 27 authorities in real time.
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