PlainRecalls
FDA Devices Moderate Class II Terminated

Philips Healthcare DigitalDiagnost stationary X-ray system

Reported: June 15, 2016 Initiated: November 10, 2015 #Z-1695-2016

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.

Details

Recalling Firm
Philips Healthcare
Units Affected
160
Distribution
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.
Location
Andover, MA

Frequently Asked Questions

What product was recalled?
Philips Healthcare DigitalDiagnost stationary X-ray system. Recalled by Philips Healthcare. Units affected: 160.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 15, 2016. Severity: Moderate. Recall number: Z-1695-2016.