Reported Dec 1, 2021 · Ongoing
ProxiDiagnost N90 is multi-functional general R/F systems.
Philips Healthcare
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Healthcare · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
- ProxiDiagnost N90 is multi-functional general R/F systems.
- Lot codes and dates
- ProxiDiagnost N90
- Amount recalled
- 281 in total
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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