Home / Recalls / Medical Devices
Philips Healthcare recalls CombiDiagnost R90 is multi-functional general R/F systems.
Recalled December 1, 2021 · FDA recall Z-0241-2022 · 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. · FDA Class II
Units
281 in total
Sold at
US Nationwide Distribution
Description
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.
Product
CombiDiagnost R90 is multi-functional general R/F systems.
Manufacturer(s)
Philips Healthcare
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →