CLASS II Device recall · Reported 21 Feb 2018 · FDA Enforcement Report
Ingenuity TF PET/CT recalled by Philips Medical Systems
Philips Medical Systems (Cleveland) is recalling Ingenuity TF PET/CT (, distributed in California, Illinois, New York, Ohio, Pennsylvania. The recall was initiated on 11 Dec 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0562-2018
- FDA event ID
- 79008
- Recalling firm
- Philips Medical Systems (Cleveland), Cleveland, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Dec 2017
- FDA classified
- 9 Feb 2018
- Reported
- 21 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 11 Dec 2017 | Recall initiated by company | |
| 9 Feb 2018 | Classified by FDA | +60 days |
| 21 Feb 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
Worldwide Distribution - US Distribution to the states of : CA, OH, IL, PA and NY.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
Worldwide Distribution - US Distribution to the states of : CA, OH, IL, PA and NY.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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