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Philips Electronics North America Corporation recalls Philips DuraDiagnost stationary X-ray system
Recalled September 7, 2016 · FDA recall Z-2682-2016 · Philips Electronics North America
Hazard
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)]. · FDA Class II
Units
15
Sold at
US Distribution to the states of : ME, NE, OR, CA, TX, NC, WA and OH.
Description
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)].
Product
Philips DuraDiagnost stationary X-ray system
Manufacturer(s)
Philips Electronics North America Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →