FDA-Device2021-12-01Class II
CombiDiagnost R90 is multi-functional general R/F systems.
Philips Healthcare
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.
Sold states
US Nationwide Distribution
Affected count
281 in total
Manufactured in
3000 Minuteman Rd, Andover, MA, United States
Products
CombiDiagnost R90 is multi-functional general R/F systems.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0241-2022Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief