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.
What this means for you
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
- Hazard
- dosing-error
- contrast-volume-error
Distribution
Distributed nationwide across the United States.
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