FDA-Device2016-09-07Class II
Philips DuraDiagnost stationary X-ray system
Philips Electronics North America Corporation
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)].
Sold states
US Distribution to the states of : ME, NE, OR, CA, TX, NC, WA and OH.
Affected count
15
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
Philips DuraDiagnost stationary X-ray system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2682-2016Don't want to check this manually?
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