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Recall Observatory FDA recall evidence

Device product

Philips Healthcare DuraDiagnost stationary X-ray system

Z-1696-2016

November 10, 2015

Class II

Product summary

Firm
Philips Healthcare
Event
Event 74083
Status
Terminated
Classification
Class II
Quantity
5
Official record key
device-enforcement:Z-1696-2016

Official wording

Reason: The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image.

Code information: software version - 4.0.2, 4.0.3, 4.0.4 into 4.0.5

Distribution pattern: USA (nationwide) Distribution to the states of : ( DuraDiagnost) to the states of : OH, CA, WA and NE. (DigitalDiagnost) to the states of : AK, AZ, AL, CA, CT, CO, DE, FL, GA, HI, ID, KY, LA, MA, MN, MD, MS, ME, MO, NE, NY, ND, OH and PA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image.