728332 IQon Spectral CT-Computed Tomography X-ray system
Check against the official notice below — it lists the full affected range.
Philips North America is recalling certain IQon Spectral CT (computed tomography) X-ray systems because of a software issue in SynchRight P3T (Personalized Patient Protocol). When patient weight unit preferences are set to pounds, the software calculates an increased volume of contrast material and recommends this higher volume to be administered to patients. The affected systems were distributed nationwide in Arizona, Florida, Louisiana, Minnesota, Nebraska, Nevada, New York, and Pennsylvania, with specific serial numbers identified in the recall.
The recall record does not specify a remedy or instructions for what consumers or healthcare facilities should do in response to this issue.
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: N/A Lot/code info: Serial Number/UDI: 60001 (01)00884838059542(21)60001, 60005 (01)00884838059542(21)60005, 60015 (01)00884838059542(21)60015, 60017 (01)00884838059542(21)60017, 860026 (01)00884838059542(21)860026, 860035 (01)00884838059542(21)860035, 860053 (01)00884838059542(21)860053 860074 (01)00884838059542(21)860074, 860108 (01)00884838059542(21)860108, 860109 (01)00884838059542(21)860109. Software Version 4.7.7 SynchRight Option
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.