Device product
Philips Healthcare DigitalDiagnost stationary X-ray system
Z-1695-2016
Product summary
- Event
- Event 74083
- Status
- Terminated
- Classification
- Class II
- Quantity
- 160
- Official record key
device-enforcement:Z-1695-2016
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 - 4.0.4, 4.1.2, 4.1.3.
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
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.