field safety notice

field safety notice

A term defined by the European Commission DG Enterprise and Industry as a communication to customers and/or users, sent out by a manufacturer or its representative in relation to a Field Safety Corrective Action (see there).
References in periodicals archive ?
A field safety notice was also registered for the hydrosurgery device due to its manufacturing error in reported headpieces.
In the same year, laboratory professionals received an urgent field safety notice related to more than 20 lot numbers of a troponin I immunoassay which showed >10 percent change in results for samples with biotin levels [less than or equal to]10 ng/mL; this was inconsistent with the product's instructions for use.
With respect to medical devices affected by corrections limited to labeling (e.g., updating the label with new user warnings), new supply will be permitted, provided that such supply is accompanied by the product owners field safety notice (FSN), which is a notice the owners send to device users in relation to the FSCA.
As a result of these three reports, Haag-Streit issued a 'Field Safety Notice' (FSN) in October 2008 to all its customers--included in the FSN is a field test for clinicians to check the tonometer prism for cracks and scratches.
New definitions of existing concepts, Field Safety Corrective Action (FSCA), Field Safety Notice, use error and abnormal use are introduced and will be discussed further later in this column.
Siemens sent an Urgent Field Safety Notice, dated August 21, 2013, to all affected customers.