Philips CT Scanner Recall for Dose Limit Software Defect
Philips is recalling eight Brilliance 64 and Ingenuity CT scanners because a software update allows users to disable dose alerts, potentially permitting scans that exceed safety limits.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a structural software defect that allows users to bypass safety limits, potentially leading to significant injury through excessive radiation exposure.
Plain-English summary
Philips Medical Systems (Cleveland) Inc. is recalling eight units of the Brilliance 64 and Ingenuity CT whole body Computed Tomography X-Ray Systems. The recall affects specific system codes and serial numbers distributed in the United States (including Indiana and Ohio) as well as Australia, Belgium, China, Israel, and Sweden.
The recall is due to a software design defect in version 4.0.0xx379. This version does not prevent the system from scanning if the dose level exceeds a set upper dose limit for CT Brain Perfusion scanning, a restriction that was present in previous versions. While the system includes a Dose Check feature that provides notifications and alerts, users can disable this check, creating a risk of excessive radiation exposure.
Healthcare facilities and users of these specific CT scanners should contact Philips Medical Systems for instructions on how to resolve the software issue. The recall is classified as Class II by the FDA.
The recalled product
- Product
- The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 8
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 (9)
- System Code # 728231
- Serial #s: 91003
- 95157
- 9654
- 95130
- and 95504 System Code # 728326
- Serial #s: 300010
- 300030
- and 300018
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 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 · radiation exposure
See all →- HighPhilips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
- HighPhilips Recalls IQon Spectral CT Systems Due to Radiation Issue
FDA (Devices) · 2026-09-09
- HighPhilips Brilliance CT Systems Recalled for Unintended Radiation Issue
FDA (Devices) · 2026-09-09
- HighPhilips CT Systems Recalled for Unintended Radiation Performance Issues
FDA (Devices) · 2026-09-09
- HighPhilips CT Systems Recalled for Unintended Radiation Performance Issues
FDA (Devices) · 2026-09-09
Similar recalls
- HighPhilips Recalls Brilliance 64 and Ingenuity CT Scanners Due to Software Anomalies
FDA (Devices) · 2013-01-23
- ModeratePhilips Brilliance 64 and Ingenuity CT Systems Software Update Recall
FDA (Devices) · 2013-03-20
- HighPhilips CT Scanners Recalled for Image Artifacts Impairing Diagnostic Quality
FDA (Devices) · 2013-07-10
- ModeratePhilips CT Systems Recalled for Software Image Overlap Defect
FDA (Devices) · 2014-09-24
- HighPhilips CT Scanners Recalled for Patient Selection and Scan Safety Issues
FDA (Devices) · 2013-07-03
- ModeratePhilips Ingenuity CT System Recalled for Software Issues
FDA (Devices) · 2018-02-14