FDA-Device2020-04-22Class II
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.
Shanghai United Imaging Healthcare Co., Ltd.
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.
Sold states
US Nationwide distribution in the state TX.
Affected count
2 units
Manufactured in
No. 2258 Chengbei Rd, Jiading Ind., Shanghai, China
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1708-2020Don't want to check this manually?
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