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).

Mentioned in ?

Field Safety Corrective Action

References in periodicals archive ?

A field safety notice was also registered for the hydrosurgery device due to its manufacturing error in reported headpieces.

Hydrosurgery System Market Insights and Major Trends Encouraging Growth Until the End of 2026

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.

Strategies for combating biotin interference: what do labs need to know--and do?

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.

Singapore,United States : Singapores New Risk-Based Approach for Medical Devices Undergoing Corrective Action

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.

Alert issued on tonometer prism

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.

The newest vigilance guidance explained

Siemens sent an Urgent Field Safety Notice, dated August 21, 2013, to all affected customers.