Field Safety Corrective Action
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Field Safety Corrective ActionA term defined by the European Commission DG Enterprise and Industry as an action taken by a manufacturer 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 should be notified via a Field Safety Notice.
Field Safety Corrective Actions, examples
• 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given by manufacturer regarding the use of the device—e.g., where the device is no longer on the market or has been withdrawn but could still possibly be in use (e.g., implants), or change in analytical sensitivity or specificity for diagnostic devices.