Field Safety Corrective Action (FSCA)

A Field Safety Corrective Action is an action taken by a manufacturer to report any technical or medical reason leading to a systematic recall of devices of the same type by the manufacturer to the National Competent Authority.

Field Safety Corrective Action

A Field Safety Corrective Action is used to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device that is already placed on the market. Such actions are notified via a Field Safety Notice.

Field Safety Corrective Action in the European Union

The FSCA may include; the return of a medical device to the supplier, device modification, device exchange, device destruction, retrofit by purchaser of manufacturer’s modification or design change, advice given by manufacturer regarding the use of the device (e.g. where the device is no longer on the market or has been withdrawn but could still possibly be in use e.g. implants) or change in analytical sensitivity or specificity for diagnostic devices, which might lead to or might have led to the death of a patient, user or to a serious deterioration in his state of health.