728333 Spectral CT 7500 -Computed Tomography X-ray system
Check against the official notice below — it lists the full affected range.
Philips North America is recalling one Spectral CT 7500 computed tomography X-ray system due to a software issue in the SynchRight P3T (Personalized Patient Protocol) application. When patient weight unit preferences are set to pounds, the software calculates an increased contrast volume recommendation for patients undergoing CT scans.
The recalled system has serial number 10019, operates SynchRight software version 5.0.0, and was distributed in Arizona, Florida, Louisiana, Minnesota, Nebraska, Nevada, New York, and Pennsylvania. The source document does not specify what actions affected consumers should take in response to this recall.
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: 1 unit Lot/code info: Serial Number/UDI: 10019 (01)00884838101111(21)10019 Software Version 5.0.0 SynchRight Option
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.