728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades
Check against the official notice below — it lists the full affected range.
Philips North America has recalled three Brilliance iCT-Computed Tomography X-ray systems due to a software issue in the SynchRight P3T (Personalized Patient Protocol) software. When patient weight unit preferences are set to pounds, the software incorrectly calculates and recommends increased contrast volume for patients undergoing CT scans. The affected systems are identified by specific serial numbers and are running software version 4.1.10 and have been distributed nationwide to facilities in Arizona, Florida, Louisiana, Minnesota, Nebraska, Nevada, New York, and Pennsylvania.
The recall notice does not specify a remedy or corrective action for affected consumers or healthcare facilities to take.
Written by software from the official notice below. Not reviewed by a lawyer.
When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.
Reason for recall: When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient. Distribution: US Nationwide distribution in the states of AZ, FL, LA, MN, NE, NV, NY, PA. Quantity: 3 units Lot/code info: S/N UDI: 87013 (01)00884838059474(21)87013 87008 (01)00884838059474(21)87008 87011 (01)00884838059474(21)87011 Software Version 4.1.10 SynchRight Option
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.