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Shanghai United Imaging Healthcare Co., Ltd. recalls Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx
Recalled April 22, 2020 · FDA recall Z-1708-2020 · Shanghai United Imaging Healthcare
Hazard
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. · FDA Class II
Units
2 units
Sold at
US Nationwide distribution in the state TX.
Description
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.
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.
Manufacturer(s)
Shanghai United Imaging Healthcare Co., Ltd.
Made in
China
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →