Shanghai United Imaging Healthcare Co., Ltd.: Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage: This system is intended to be oper

Is my product affected?

Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatme

• UPC 06971576832026

Check against the official notice below — it lists the full affected range.

What happened

Shanghai United Imaging Healthcare Co., Ltd. is recalling three uMI 550 Positron Emission Tomography and Computed Tomography systems distributed nationwide in the United States, including Texas. The affected systems use software version R001.3.0.0.750505 and have serial numbers 200017, 200023, and 200024. The issue involves a malfunction where the CT Hounsfield unit curve may not display in real time when using the bolus tracking protocol with the tracker scan function.

When this malfunction occurs, clinical scanning protocols must be started manually instead of automatically, which may affect image enhancement and could require patients to undergo repeat scans. The recall record does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

In affected software version, of Positron emission tomography and computed tomography system, the CT Hounsfield unit curve may not display in real time when using the bolus tracking protocol with the tracker scan function. If this occurs, the subsequent clinical scanning protocols will need to be started manually, which may effect image enhancement, and may result in patient rescan.

Details from the source

Reason for recall: In affected software version, of Positron emission tomography and computed tomography system, the CT Hounsfield unit curve may not display in real time when using the bolus tracking protocol with the tracker scan function. If this occurs, the subsequent clinical scanning protocols will need to be started manually, which may effect image enhancement, and may result in patient rescan. Distribution: US Nationwide distribution including in the state of TX. Quantity: 3 Lot/code info: UDI: 06971576832026, Software Version: R001.3.0.0.750505, Serial Numbers: 200017, 200023, 200024

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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