Philips Electronics North America Corporation recalls Philips DuraDiagnost stationary X-ray system
- Recall date
- September 17, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2682-2016
- FDA classification
- Class II
- Brand / firm
- Philips Electronics North America Corporation
- Sold / distributed
- US Distribution to the states of : ME, NE, OR, CA, TX, NC, WA and OH.
Why it was recalled
Buttons or keys on the monitor allow the user to turn the volume setting down to 0", in which case the beep will not be heard at the conclusion of an exposure, as required 21 CFR 1020.31(j), and the Height-Adjustable Tabletop is missing the required labels [21 CFR 1010.2., 21 CFR 1010.3(a), and 21 CFR 1020.30(3)].
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Philips DuraDiagnost stationary X-ray system
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