Philips Healthcare recalls DigitalDiagnost C90

Recall date

September 22, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0239-2022

FDA classification

Class II

Brand / firm

Philips Healthcare

Sold / distributed

US Nationwide Distribution

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

DigitalDiagnost C90