Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2013 - (Recall #: Z-1029-2013)

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 that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.

Product Classification:

Class II

Date Initiated: December 20, 2012

Date Posted: April 10, 2013

Recall Number: Z-1029-2013

Event ID: 64393

Reason for Recall:

Issues have been detected in the Ingenuity TF PET/CT currently running software version 4.0.60605.0 that if they were to re-occur, could cause a risk for patients, users or service personnel, including inaccurate standard uptake values (SUV). Philips Medical Systems (Cleveland), Inc. is issuing a software update to address the issues.

Status: Terminated

Product Quantity: 1

Code Information:

Model #: 882456; Serial #: 2004

Distribution Pattern:

Distributed to one customer in Ohio.

Voluntary or Mandated:

Voluntary: Firm initiated