CLASS II Device recall · Reported 20 Feb 2019 · FDA Enforcement Report
Ingenuity TF PET/CT (non-RoHS) recalled by Philips Medical Systems
Philips Medical Systems (Cleveland) is recalling Ingenuity TF PET/CT (non-RoHS), distributed nationwide in the US. The recall was initiated on 19 Dec 2018 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-0823-2019
- FDA event ID
- 82033
- Recalling firm
- Philips Medical Systems (Cleveland), Cleveland, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Dec 2018
- FDA classified
- 12 Feb 2019
- Reported
- 20 Feb 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 19 Dec 2018 | Recall initiated by company | |
| 12 Feb 2019 | Classified by FDA | +55 days |
| 20 Feb 2019 | Published in enforcement report | +8 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 update is being issued to correct multiple issues identified in the previous software version.
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 (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).
Where it was distributed
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.
Questions about this recall
Why was it recalled?
A software update is being issued to correct multiple issues identified in the previous software version.
Which lots are affected?
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
Where was it sold?
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.
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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Other Imaging Equipment recalls
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| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |