Philips Ingenuity CT System Recalled for Software Defects
Philips Healthcare is recalling Ingenuity CT systems due to software defects that cause incorrect scan lengths and dose calculations.
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, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Philips Healthcare is recalling the Ingenuity CT Computed Tomography X-Ray System due to software defects. The recall affects software versions 4.13, 4.14, and 4.15.
The identified defects include shortened sagittal results for axial scans, display errors when creating multi-planner reconstructions, and scan length changes when the field of view is altered. Additionally, the DoseRight algorithm may miscalculate CTDI values, and scan lengths may change during subsequent axial results or near specific lengths of 135mm or 184mm.
The affected units were distributed across numerous US states, including Arizona, Pennsylvania, Florida, and Washington. Healthcare facilities using these systems should contact Philips Healthcare for further instructions on resolving the software issues.
The recalled product
- Product
- Philips Healthcare Ingenuity CT Computed Tomography X-Ray System
- Manufacturer
- Philips Healthcare
- Affected units
- 423
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)
- Software v. 4.13
- 4.14 and 4.15.
Distribution
Part of a larger recall action
This product is one of 7 recalled by Philips Healthcare under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
Same manufacturer · Philips Healthcare
See all →- HighPhilips Incisive CT Software Version 5.0 Recall for Scan Parameter Issues
FDA (Devices) · 2023-10-11
- HighPhilips StentBoost Live imaging system acquisition malfunction recall
FDA (Devices) · 2022-04-13
- HighAzurion Medical Imaging System Software Defect Affects Patient Dose Control
FDA (Devices) · 2022-03-30
- HighPhilips CombiDiagnost R90 X-ray systems missing required radiation warning labels
FDA (Devices) · 2021-12-01
- ModerateMedical X-Ray Systems Missing Required Radiation Warning Labels
FDA (Devices) · 2021-12-01
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 CT Scanner Software Error Recalled by FDA
FDA (Devices) · 2015-12-23
- HighPhilips Ingenuity Core CT Scanner Software Recall
FDA (Devices) · 2015-12-23
- HighPhilips Ingenuity CT Scanners Recalled for Software and Hardware Defects
FDA (Devices) · 2015-08-05
- HighPhilips CT Scanner Software Error May Alter Scan Length
FDA (Devices) · 2015-12-23
- ModeratePhilips Ingenuity CT Systems Recalled for Software Error in Data Transmission
FDA (Devices) · 2016-04-20
- ModeratePhilips Ingenuity CT System Recalled for Software Issues
FDA (Devices) · 2018-02-14