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FDASeptember 22, 2021device

ProxiDiagnost N90 is multi-functional general R/F systems.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

philips healthcarephilips

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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ProxiDiagnost N90 is multi-functional general R/F systems. — Recall Details · AllClear