Philips CT Systems Recalled for Unintended Radiation Performance Issues
Philips is recalling specific CT systems due to an unintended radiation issue that could affect equipment performance.
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 recall involves a medical device with a potential radiation hazard where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Philips North America LLC is recalling specific Philips CT systems, including the Ingenuity CT, IQon, iCT, and Brilliance CT 64 models. The recall involves specific product codes and software version 4.4.10.x.
The recall was initiated because Philips identified an unintended radiation issue with these systems. This issue could affect the performance of the equipment.
The affected products were distributed in the US and US Territories. Consumers and healthcare providers should contact Philips for further instructions regarding the recall.
The recalled product
- Product
- Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Software 4.4.10.x
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — CT Scanner
- Hazard
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 (3)
- UDI: Ingenuity CT Upgrades (01)00884838098701
- Ingenuity CT China (01)00884838059863
- Ingenuity Core 128 Elite Brazil: N/A
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Philips North America Llc
See all →- HighPhilips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
- ModeratePhilips Achieva 1.5T MRI Systems Recalled for Software Memory Issue
FDA (Devices) · 2026-09-30
- ModeratePhilips MR 7700 MRI Systems Recalled for Software Issue
FDA (Devices) · 2026-09-30
- ModeratePhilips Ingenia MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30
- ModeratePhilips Intera 1.5T MRI Systems Recalled for Software Issue
FDA (Devices) · 2026-09-30
Same hazard · radiation exposure
See all →- HighPhilips Recalls IQon Spectral CT Systems Due to Radiation Issue
FDA (Devices) · 2026-09-09
- HighPhilips CT Systems Recalled for Unintended Radiation Performance Issues
FDA (Devices) · 2026-09-09
- HighPhilips Brilliance CT Systems Recalled for Unintended Radiation Issue
FDA (Devices) · 2026-09-09
- HighPhilips Ingenuity CT Scanners Recalled Due to Bolus Tracking Trigger Issue
FDA (Devices) · 2026-08-05
- HighPhilips CT Scanners Recalled Due to Bolus Tracking Trigger Issue
FDA (Devices) · 2026-08-05
Similar recalls
- HighPhilips CT Systems Recalled for Unintended Radiation Performance Issues
FDA (Devices) · 2026-09-09
- HighPhilips Brilliance CT Systems Recalled for Unintended Radiation Issue
FDA (Devices) · 2026-09-09
- HighPhilips Recalls IQon Spectral CT Systems Due to Radiation Issue
FDA (Devices) · 2026-09-09
- ModeratePhilips Ingenuity CT System Recalled for Software Issues
FDA (Devices) · 2018-02-14
- ModeratePhilips CT System Recalled for Software Issues
FDA (Devices) · 2018-02-14
- ModeratePhilips Ingenuity Core CT System Software Recall
FDA (Devices) · 2018-02-14