Philips Brilliance 64 CT Systems Recalled for Software Error
Philips Medical Systems is recalling 18 Brilliance 64 CT systems due to a software error involving the filament on timer.
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, which typically involves a situation where use of the product may cause temporary or medically reversible adverse health consequences. No specific injuries or illnesses are reported in the source text.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 18 units of the Brilliance 64 Computed Tomography (CT) X-ray systems. These devices are intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
The recall is being conducted due to a software error related to the filament on timer. The affected units were distributed worldwide, including in the United States and numerous international locations.
Healthcare facilities should contact Philips Medical Systems for instructions on how to address the software error. Consumers should not use the affected devices until the issue is resolved.
The recalled product
- Product
- Brilliance 64 728232 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. These devices may include signal analysis and display equipment, patient and…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 18
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 (17)
- 122921
- 123029
- 123092
- 123096
- 123116
- 123117
- 123148
- 123150
- 123164
- 123170
- 123172
- 123176
- 123179
- 123180
- 123182
- 123183
- 123185 and 123191
Distribution
Part of a larger recall action
This product is one of 5 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 5 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 error
See all →- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- HighPhilips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
- HighBard EnCor EnCompass Breast Biopsy System Software Recall
FDA (Devices) · 2026-10-07
- ModerateBeckman Coulter AU480 Chemistry Analyzer Software Error Recall
FDA (Devices) · 2026-10-07
- HighPhilips EPIQ Elite Ultrasound System Recalled for Software Error
FDA (Devices) · 2026-09-30
Similar recalls
- ModeratePhilips Brilliance 64 CT Systems Recalled for Software Data Transmission Error
FDA (Devices) · 2016-04-20
- ModeratePhilips Brilliance 64 CT Systems Recalled for Software Defect
FDA (Devices) · 2016-08-17
- ModeratePhilips Brilliance 64 CT Systems Recalled for Software Mapping Error
FDA (Devices) · 2016-06-08
- HighPhilips Brilliance 64 CT System Recalled for Software Defects
FDA (Devices) · 2015-12-16
- ModeratePhilips Brilliance 16 CT Systems Recalled for Software Defect
FDA (Devices) · 2016-08-17
- ModeratePhilips Brilliance 64 CT System Recalled for Software Issues
FDA (Devices) · 2018-02-14