—#170617

Product

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).

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K172406
Affected lot / code info: 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

Why it was recalled

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

Root cause (FDA determination)

Software design

Action the firm took

The firm, Philips, sent an "URGENT - Medical Device Correction" letters dated 12/19/18 to its customers. The letter describes the products, problem and actions to be taken. The customers were instructed to: review the information including (Ingenuity TF PET/CT running software version 4.0.2 (4.0.0.26645) Software Issues) Issues with all members of your staff who need to be aware of the contents of this communication; retain a copy with the equipment Instruction for Use and If you need any further information or support concerning these issues, please contact your local Philips representative. or the Sr. Manager, Post Market Surveillance at 440-869-4807 or email: Holly.Lee@philips.com. For North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377, follow the prompts).

Recalling firm

Firm: Philips Medical Systems (Cleveland) Inc
Address: 595 Miner Rd, Cleveland, Ohio 44143-2131

Distribution

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.

Timeline

Recall initiated: 2018-12-19
Terminated: 2021-08-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #170617. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.