Brilliance iCT Computed Tomography Systems Recalled for Contrast Dosing Error
Philips Brilliance iCT CT systems with SynchRight P3T software may recommend incorrect contrast volume when patient weight is entered in pounds, potentially affecting patient safety.
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: FDA Class II medical device recall for software-based dosing calculation error. No reported illnesses or injuries, but the hazard involves potential patient harm from incorrect contrast volume recommendations.
Plain-English summary
Philips North America LLC is recalling Brilliance iCT Computed Tomography X-ray systems (models 728306 and 728305 upgrades) due to a software error in the SynchRight P3T (Personalized Patient Protocol) option.
The SynchRight P3T software contains a calculation error that occurs when patient weight unit preferences are set to pounds. When this setting is used, the software will recommend an increased contrast volume compared to what should be recommended. This dosing miscalculation could potentially lead to inappropriate patient exposure to contrast agent.
Three units have been identified as affected and are located in healthcare facilities across Arizona, Florida, Louisiana, Minnesota, Nebraska, Nevada, New York, and Pennsylvania. The affected software version is 4.1.10.
Healthcare providers using affected systems should contact Philips North America LLC for information about software updates or corrective actions to prevent the dosing error when weight units are set to pounds.
The recalled product
- Product
- 728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades
- Manufacturer
- Philips North America Llc
- Affected units
- 3
Distribution
Part of a larger recall action
This product is one of 5 recalled by Philips North America Llc 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 North America Llc
See all →- HighPhilips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
- ModeratePhilips Achieva 1.5T MRI Systems Recalled for Software Memory Issue
FDA (Devices) · 2026-09-30
- ModeratePhilips MR 7700 MRI Systems Recalled for Software Issue
FDA (Devices) · 2026-09-30
- ModeratePhilips Ingenia MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30
- ModeratePhilips MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30
Same hazard · dosing error
See all →- SevereLevothyroxine Sodium Tablets Recalled for Subpotency
FDA (Drugs) · 2026-07-29
- SevereMajor Pharmaceuticals Recalls Levothyroxine Sodium Tablets Over Subpotency
FDA (Drugs) · 2026-07-29
- HighPhothera 200 phototherapy calibration certificates had outputs reversed
FDA (Devices) · 2026-06-10
- HighMedline eye trays contain insulin syringes labeled as tuberculin syringes
FDA (Devices) · 2026-06-03
- HighMethylprednisolone dose packs recalled over misoriented blister foil dosing information
FDA (Drugs) · 2026-02-04
Similar recalls
- HighPhilips Brilliance iCT CT System Software Defect Recall
FDA (Devices) · 2016-06-15
- HighPhilips Brilliance iCT SP CT System Recalled for Software Defects
FDA (Devices) · 2016-06-15
- HighPhilips Brilliance iCT CT Systems Recalled for Software and Hardware Defects
FDA (Devices) · 2015-08-05
- HighPhilips Brilliance iCT CT Systems Recalled for Software Defects
FDA (Devices) · 2018-01-31
- HighPhilips Brilliance iCT Scanners Recalled for Misleading Calcium Score Reports
FDA (Devices) · 2018-11-07
- HighPhilips Brilliance CT Systems Recalled for Dose Calculation Issue
FDA (Devices) · 2014-02-05