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Recall Observatory FDA recall evidence

Device product

Philips DuraDiagnost stationary X-ray system

Z-2682-2016

September 17, 2015

Class II

Product summary

Firm
Philips Electronics North America Corporation
Event
Event 74685
Status
Terminated
Classification
Class II
Quantity
15
Official record key
device-enforcement:Z-2682-2016

Official wording

Reason: 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)].

Code information: SN: 140054 140059 150013 150014 150039 150041 150042 150052 150053 150055 150056 150059 150061 150091 150093

Distribution pattern: US Distribution to the states of : ME, NE, OR, CA, TX, NC, WA and OH.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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)].