Z-1695-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 15, 2016
- Initiation Date
- November 10, 2015
- Termination Date
- May 3, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 160
Product Description
Philips Healthcare DigitalDiagnost stationary X-ray system
Reason for Recall
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.
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.
Code Information
software version - 4.0.4, 4.1.2, 4.1.3.