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CATÉGORIE: SAFETY SURVEILLANCE
Rappel de dispositif médical
Une action prise par un fabricant pour corriger ou retirer un dispositif commercialisé qui viole les réglementations FDA ou peut présenter un risque sanitaire. Classifié en Classe I, II ou III.
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 medical device recall (or field action) corrects or removes a distributed device that violates law or may pose risk. FDA classifies US recalls as Class I–III by health hazard.
PROCESS / STEPS
- Detect issue via complaints, manufacturing deviations, or regulator signals.
- Assess health hazard and decide correction/removal strategy.
- Notify regulators and customers; execute effectiveness checks.
- Document root cause and CAPA; close with status updates.
EXAMPLES
- Class I infusion pump software defect with serious injury risk.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to Rappel de dispositif médical across 27 authorities in real time.
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