medical Class II Updated 2020-04-22

Shanghai United Imaging Healthcare Co., Ltd. recalls Positron Emission Tomograpy and Computed Tomography System,

Recalled Product

Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx Only, CE 0197, UDI: (01)06971576832026 - 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 treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.

Hazard / Issue

Potential sporadic software bugs in R001.3.0.0.750505 software version may cause an issue with the PET acquisition raw data causing reconstruction problems during PET/CT scanning and could possibly cause rescans of patients with additional dose.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers: 200017 and 200023
View official government recall

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