Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system
Check against the official notice below — it lists the full affected range.
Philips North America is recalling two CT5000 Ingenuity Plus/Pro/Premium computed tomography X-ray systems distributed across eight states. The systems are affected by a software issue in SynchRight P3T (Personalized Patient Protocol) that causes increased contrast volume recommendations when patient weight unit preferences are set to pounds instead of kilograms, potentially leading to patients receiving more contrast than appropriate.
The affected systems are located in Arizona, Florida, Louisiana, Minnesota, Nebraska, Nevada, New York, and Pennsylvania. The recall record does not specify a remedy or corrective action that affected consumers should 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: 2 units Lot/code info: Model: 728321 S/N UDI: 40012 (01)00884838059498(21)40012 Model: 728332 40004 (01)00884838059504(21)40004 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.