BfArM - Federal Institute for Drugs and Medical Devices

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Reporting Recalls

Field Safety Corrective Actions (FSCA)

FSCA Report Form (Initial, Final and Follow-up) according to § 3 (1) of the Ordinance on Medical Devices Vigilance by the Manufacturer, Authorised Representative or Importer (or Distributor)

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Measures taken by manufacturers

Customer information contains information from manufacturers about recalls of medical devices carried out on their own responsibility.

Customer information on manufacturer measures