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 ?
5 million, net of tax) associated with the field safety notice in response to results of the SERVE-HF clinical trial and second, donations of $6.
0 million in relation to the SERVE-HF field safety notice, gross margin in the fourth quarter was 57.
Non-GAAP diluted earnings per share, excluding the impact of SERVE-HF field safety notice expenses, donations, restructuring expenses and amortization of acquired intangible assets[sup.
Non-GAAP operating income (excluding the impact of SERVE-HF field safety notice expenses, donations, restructuring expenses and amortization of acquired intangible assets)
ResMed excludes SERVE-HF field safety notice expenses, donations, restructuring expenses and amortization of acquired intangible assets from their evaluation of ongoing operations and believes investors benefit from excluding these charges to facilitate a more meaningful evaluation of current operating performance.
Siemens sent an Urgent Field Safety Notice, dated August 21, 2013, to all affected customers.
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.
There is no surprise here, but the FSCA needs to be reported in the Field Safety Notice template form provided in Annex 4, Report Form: Field Safety Corrective Action.
It also is advisable that a draft Field Safety Notice be submitted 48 hours before it is disseminated for comment by a relevant competent authority, defined as where the manufacturer or AR has registered its place of business, where most of the affected devices are on the market, or any other appropriate national competent authority.
In April 2012, Stryker issued an Urgent Field Safety Notice to surgeons and hospitals, which acknowledged reports of heavy metal contamination, such as that experienced by the eight total plaintiffs.