medical Class II Updated 2021-12-01

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

Distribution: Nationwide (United States)
Lot/Code Info: ProxiDiagnost N90
View official government recall

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