Philips Ingenuity TF PET/CT Software Update Corrects Multiple Issues
Philips is issuing a software update for 24 Ingenuity TF PET/CT systems to correct multiple issues identified in the previous software version.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text describes a software update to correct issues but does not report any injuries, illnesses, or specific high-risk hazards, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is issuing a software update for the Ingenuity TF PET/CT (non-RoHS), Model Number 882456. This diagnostic imaging system combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) to produce cross-sectional images and images of radiopharmaceutical distribution. The recall involves 24 units with serial numbers ranging from 2003 to 2027.
The software update is being issued to correct multiple issues identified in the previous software version. The source text does not specify the exact nature of these issues or report any associated injuries or illnesses.
The affected devices were distributed worldwide, including in the United States (California, Illinois, New York, Ohio, and Pennsylvania) and in Australia, Austria, Columbia, Egypt, France, Germany, India, Italy, Lithuania, Netherlands, and Switzerland. Users should contact the manufacturer to obtain and install the software update.
The recalled product
- 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…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 24
Distribution
Related recalls
Same manufacturer · Philips Medical Systems (Cleveland) Inc
See all →- HighRadiation planning software recalled over image errors in three patient orientations
FDA (Devices) · 2025-09-24
- HighPinnacle 3 radiation planning software may miscalculate stopping power ratio
FDA (Devices) · 2025-08-13
- HighPinnacle3 Radiation Therapy Planning System dose-calculation software error
FDA (Devices) · 2022-09-21
- SeverePhilips Forte Gamma Camera System Recalled Due to Detector Falling Hazard
FDA (Devices) · 2019-11-13
- SeverePhilips Recalls Forte Gamma Camera Systems Due to Detector Fall Risk
FDA (Devices) · 2019-11-13
Same hazard · software defect
See all →- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uMI 550 PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModeratePhilips SmartPath to MR 7700 Recalled for Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
Similar recalls
- HighPhilips Ingenuity TF PET/CT Software Update Addresses Potential Safety Risks
FDA (Devices) · 2013-04-10
- ModeratePhilips Ingenuity TF PET/CT Software Recall for Reconstruction Failures
FDA (Devices) · 2018-02-21
- HighPhilips Ingenuity TF PET/CT Software Recall for Potential Radiopharmaceutical Re-injection Risk
FDA (Devices) · 2013-11-06
- ModeratePhilips Ingenuity TF PET/CT Recalled for Cardiac Image Labeling Error
FDA (Devices) · 2019-08-14
- HighPhilips Ingenuity CT Software Recall for Performance Issues
FDA (Devices) · 2016-08-17
- ModeratePhilips Ingenuity CT Systems Recalled for Software Error in Data Transmission
FDA (Devices) · 2016-04-20