FDA recall Z-0239-2022

Product

DigitalDiagnost C90

Reason for recall

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.

Distribution

US Nationwide Distribution

Key facts

Status

Ongoing

Initiation date

2021-09-22

Report date

2021-12-01

Voluntary/Mandated

FDA Mandated

Location

Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0239-2022