Philips Healthcare recalls ProxiDiagnost N90 is multi-functional general R/F systems.
Recalled Product
ProxiDiagnost N90 is multi-functional general R/F systems.
Hazard / Issue
The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards. This includes the Radiation Warning Label [21CFR 1020.30 (j)] and the X-ray control certification statement [21 CFR 1010.2]. Philips has determined that some systems at customer locations did not have these labels applied.
Issued by
FDA
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