Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2013 - (Recall #: Z-0897-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Ingenuity TF PET/CT. Diagnostic imaging system

Product Classification:

Class II

Date Initiated: January 21, 2013

Date Posted: March 6, 2013

Recall Number: Z-0897-2013

Event ID: 64403

Reason for Recall:

The system may not default to the same gating trigger with which the data were acquired. This could cause a risk for patients.

Status: Terminated

Product Quantity: 1 Unit

Code Information:

Model # 882456, Serial # 2004. Units currently running Ingenuity TF PET/CT system software version 4.0.0.26635.

Distribution Pattern:

Distributed only in Ohio.

Voluntary or Mandated:

Voluntary: Firm initiated