Philips Brilliance iCT SP CT Systems Recalled for Software Defects
Philips Medical Systems is recalling two Brilliance iCT SP CT systems due to software issues affecting image quality, dose control, and heart rate measurement.
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 software defects that could lead to incorrect dose administration or inaccurate patient data (heart rate), representing a risk of harm where injury has not yet been reported.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling two units of the Brilliance iCT SP Computed Tomography X-ray Systems. The recall involves specific serial numbers 200047 and 200121, model #728311. These devices are intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data.
The recall is due to five identified software issues: Fast Get Ready is incorrectly enabled during service procedures; contrast annotation is missing for some images when manual contrast was administered; dot artifacts are intermittently present after startup; heart rate measured values incorrectly remain constant for some heart rate change conditions; and DoseRight is incorrectly enabled when the Exam Card specified disabling it. Additionally, tube heat prediction issues were noted.
The affected units were distributed worldwide, including nationwide in the United States and in numerous international countries. No specific instructions for consumers are provided in the source text, but the recall is managed by the recalling firm.
The recalled product
- Product
- Computed Tomography X-ray Systems Brilliance iCT SP. 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
- Affected units
- 2
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 (2)
- Model #728311
- Serial #s: 200047 & 200121
Distribution
Part of a larger recall action
This product is one of 6 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 6 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 →- 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 550 PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModeratePhilips SmartPath to MR 7700 Recalled for Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
Similar recalls
- ModeratePhilips Brilliance iCT SP CT Systems Recalled for Software Error
FDA (Devices) · 2016-04-20
- HighPhilips Brilliance iCT Computed Tomography System Software Defect Recall
FDA (Devices) · 2014-12-24
- ModeratePhilips Brilliance iCT CT Systems Recalled for Software Error
FDA (Devices) · 2016-04-20
- HighPhilips Brilliance iCT CT Systems Recalled for Software Defects
FDA (Devices) · 2018-01-31
- HighPhilips Brilliance iCT SP CT System Recalled for Software Defects
FDA (Devices) · 2016-06-15
- ModeratePhilips Brilliance iCT SP CT Systems Recalled for Image Reconstruction Failure
FDA (Devices) · 2017-10-25