Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2019 - (Recall #: Z-0823-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Ingenuity TF PET/CT (non-RoHS), Model Number 882456 This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging).

Product Classification:

Class II

Date Initiated: December 19, 2018

Date Posted: February 20, 2019

Recall Number: Z-0823-2019

Event ID: 82033

Reason for Recall:

A software update is being issued to correct multiple issues identified in the previous software version.

Status: Terminated

Product Quantity: 24

Code Information:

Serial Numbers 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027

Distribution Pattern:

Worldwide distribution: US (nationwide) to states of: CA, IL, NY, OH, and PA; and to countries of: Australia, Austria, Columbia, Egypt, France, Germany, India, Italy, Lithuania, Netherlands, and Switzerland.

Voluntary or Mandated:

Voluntary: Firm initiated