Philips Brilliance BigBore CT Systems Recalled for Software Defect
Philips Medical Systems is recalling 17 Brilliance BigBore CT systems due to a software defect causing intermittently slow response of the Host.
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 indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The specific defect is a software performance issue (slow response) rather than a direct safety hazard like radiation exposure or mechanical failure, and no injuries or illnesses are reported in the source text.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 17 units of the Brilliance BigBore Radiology Computed Tomography X-ray systems. These systems 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 due to a software defect that causes intermittently slow response of the Host. The affected units are identified by Model # 728244 and specific serial numbers: 7052, 7172, 7200, 7244, 7252, 7375, 7380, 7384, 7390, 7514, 7533, 7546, 7614, 7633, 7708, 7781, and 7789.
The product was distributed to numerous states in the United States and various countries internationally. Healthcare facilities and consumers who possess these specific units should contact Philips Medical Systems for further instructions on how to resolve the software defect.
The recalled product
- Product
- Brilliance BigBore Radiology 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.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 17
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 (18)
- Model #: 728244
- Serial #s: 7052
- 7172
- 7200
- 7244
- 7252
- 7375
- 7380
- 7384
- 7390
- 7514
- 7533
- 7546
- 7614
- 7633
- 7708
- 7781
- 7789.
Distribution
Part of a larger recall action
This product is one of 7 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 7 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 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 · 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 Panvivo S PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uCT 550 CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
Similar recalls
- ModeratePhilips Brilliance BigBore CT Scanner Recalled for Image Reconstruction Error
FDA (Devices) · 2016-08-31
- HighPhilips Brilliance Big Bore CT Software Recall for Image Generation Errors
FDA (Devices) · 2018-03-14
- ModeratePhilips Recalls Brilliance BigBore CT Scanners Due to Image Reconstruction Error
FDA (Devices) · 2017-03-29
- ModeratePhilips Brilliance iCT CT Systems Recalled for Software Error
FDA (Devices) · 2016-04-20
- ModeratePhilips Brilliance CT Big Bore Oncology Software Recall
FDA (Devices) · 2016-08-31
- ModeratePhilips Brilliance 64 CT Systems Recalled for Software Data Transmission Error
FDA (Devices) · 2016-04-20