Philips Ingenuity TF PET/CT Software Update Addresses Potential Safety Risks
Philips is updating software on one Ingenuity TF PET/CT system in Ohio to fix issues that could cause inaccurate readings or pose risks to patients and staff.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The source text explicitly states that the issues 'could cause a risk for patients, users or service personnel' but does not report any actual injuries, illnesses, or deaths. This aligns with the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Philips Medical Systems (Cleveland) Inc. is recalling one Ingenuity TF PET/CT diagnostic imaging system. The device is currently running software version 4.0.60605.0 and was distributed to a single customer in Ohio. The system combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) technologies.
The recall is due to detected issues in the current software version that, if they were to re-occur, could cause a risk for patients, users, or service personnel. These risks include the generation of inaccurate standard uptake values (SUV). Philips is issuing a software update to address these specific issues.
The affected unit is identified by Model # 882456 and Serial # 2004. Customers should contact Philips Medical Systems to obtain and install the necessary software update to mitigate the potential risks associated with the identified software issues.
The recalled product
- Product
- Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model #: 882456
- Serial #: 2004
Distribution
Distributed in 1 state:
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 for Detector Fall Hazard
FDA (Devices) · 2019-11-13
- SeverePhilips Forte Gamma Camera System Recalled Due to Detector Falling Hazard
FDA (Devices) · 2019-11-13
Same hazard · inaccurate reading
See all →- HighNOxBOXi Nitric Oxide Delivery System Recalled for Oxygen Sensor Defect
FDA (Devices) · 2026-10-07
- HighMidmark IQvitals Zone Recalled for Inaccurate Blood Pressure Readings
FDA (Devices) · 2026-09-30
- HighMidmark IQvitals Zone Recalled for Inaccurate Blood Pressure Readings
FDA (Devices) · 2026-09-30
- HighMidmark IQvitals Zone Recalled for Inaccurate Blood Pressure Readings
FDA (Devices) · 2026-09-30
- HighMidmark IQvitals Zone Recalled for Inaccurate Blood Pressure Readings
FDA (Devices) · 2026-09-30
Similar recalls
- HighPhilips Ingenuity TF PET/CT Software Recall for Potential Radiopharmaceutical Re-injection Risk
FDA (Devices) · 2013-11-06
- ModeratePhilips Ingenuity TF PET/CT Software Update Corrects Multiple Issues
FDA (Devices) · 2019-02-20
- HighPhilips Ingenuity TF PET/CT System Recalled for Gating Trigger Risk
FDA (Devices) · 2013-03-06
- ModeratePhilips Ingenuity TF PET/CT Software Recall for Reconstruction Failures
FDA (Devices) · 2018-02-21
- 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