Z-0562-2018Class II

Ingenuity TF PET/CT (model 882442) running software version 4.0.2 This device is a diagnostic imaging system...

Name: Z-0562-2018 Ingenuity TF PET/CT (model 882442) running software version 4.0.2 This device is a diagnostic imaging system...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2017-12-11
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2017-12-11 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Ingenuity TF PET/CT (model 882442) running software version 4.0.2 This device is a diagnostic imaging system that combines Positron Emission Tomography (PET)... on 2017-12-11. FDA classified it as Class II and gives the reason as "A software issue causes PET reconstructions to fail intermittently. It was determined that reconstructions fail due to a negative table position (-1 value is inserted) in the raw data list file, rather than the actual...". 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-0562-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-11
Posted: 2018-02-09
Terminated: 2022-08-30
Recalling firm: Philips North America LLC
Product: Ingenuity TF PET/CT (model 882442) running software version 4.0.2 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). CT data is applied to the PET data for attenuation correction. The PET subsystem also provides for list mode, dynamic, and gated acquisitions. This system is intended for patients of all ages
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: A software issue causes PET reconstructions to fail intermittently. It was determined that reconstructions fail due to a negative table position (-1 value is inserted) in the raw data list file, rather than the actual table position. This error has been found to occur in two scenarios: 1) When the system operator cancels an acquisition a. The error will occur every time a scan is cancelled by the operator. 2) Couch position requests within the software sequence were delayed a. The error occurs intermittently, but has been found to occur more frequently when the gantry s network is heavily loaded with multiple retrospective reconstructions running in parallel. b. The error manifests to the technologist by an error message and Failed status on the Reconstruction Monitor and the error message Result {0} failed to reconstruct" on the Acquisition Workflow window during reconstruction after the patient scan has been completed. In both scenarios, the acquisition data will not be able to be reconstructed and will therefore be unusable.
Root cause tag: software
FDA root cause: Software design
Action: Philips Healthcare sent an Urgent-Field Safety Notice dated December 11, 2017. U.S. Customers will be receive the letter via USPS Certified mail. Non-U.S.. customers will receive the letter through Philips Global Markets following local regulations. Philips is informing customers of the software issues on the systems, as well as available workarounds to prevent these issues from occurring or to minimize their impact. 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 Distribution to the states of : CA, OH, IL, PA and NY.
Product codes and lots: Ingenuity TF PET/CT (model 882442) SN: 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-0562-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0562-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-09

Product code JAK

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)