Z-0823-2019Class II

Ingenuity TF PET/CT (non-RoHS), Model Number 882456 This device is a diagnostic imaging system that combines...

Name: Z-0823-2019 Ingenuity TF PET/CT (non-RoHS), Model Number 882456 This device is a diagnostic imaging system that combines...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2018-12-19
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2018-12-19 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of 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... on 2018-12-19. FDA classified it as Class II and gives the reason as "A software update is being issued to correct multiple issues identified in the previous software version". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0823-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-19
Posted: 2019-02-12
Terminated: 2021-08-03
Recalling firm: Philips North America LLC
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).
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: A software update is being issued to correct multiple issues identified in the previous software version.
Root cause tag: software
FDA root cause: Software design
Action: 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: [email protected]. For North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377, follow the prompts).
Quantity in commerce: 24
Distribution: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0823-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0823-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-20	2019-02-12

Product code KPS

K172406Class IIIngenuity TFPhilips Medical Systems (Cleveland), Inc. / cleared 2017-10-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)