Philips Brilliance 64 CT System Recalled for Software Issues
Philips Medical Systems is recalling 1,801 Brilliance 64 CT systems due to software issues in version 4.1.6.
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 specific high-risk hazards, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 1,801 units of the Philips Brilliance 64 computed tomography x-ray system. The recall is due to numerous issues related to the Brilliance iCT 4.1.6 software version.
The affected units were distributed to 26 US Government accounts. The source text does not specify the exact nature of the software issues or report any specific injuries or illnesses associated with the defect.
Healthcare facilities should contact Philips Medical Systems for further instructions on how to address the software issues. The recall number is Z-0518-2018.
The recalled product
- Product
- Philips Brilliance 64 computed tomography x-ray system
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 1,801
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by Philips Medical Systems (Cleveland) Inc 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 4 products in this recall →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 →- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uCT 550 CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uMI Panvivo S PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
Similar recalls
- HighPhilips Brilliance 64 CT System Recalled for Software Defects
FDA (Devices) · 2015-12-16
- ModeratePhilips Brilliance 64 CT Systems Recalled for Software Defect
FDA (Devices) · 2016-08-17
- HighPhilips Brilliance iCT CT Systems Recalled for Software Defects
FDA (Devices) · 2018-01-31
- ModeratePhilips Brilliance 64 CT Scanner Software Recall
FDA (Devices) · 2016-08-17
- ModeratePhilips Brilliance 64 CT Systems Recalled for Software Error
FDA (Devices) · 2016-12-14
- ModeratePhilips Brilliance 64 CT Systems Recalled for Software Mapping Error
FDA (Devices) · 2016-06-08