Philips Healthcare: Medical Device Recall in 2016 - (Recall #: Z-1695-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Philips Healthcare DigitalDiagnost stationary X-ray system

Product Classification:

Class II

Date Initiated: November 10, 2015

Date Posted: June 15, 2016

Recall Number: Z-1695-2016

Event ID: 74083

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.

Status: Terminated

Product Quantity: 160

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.

Voluntary or Mandated:

Voluntary: Firm initiated