Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550 ...



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.
Components:
Recall Date:    Aug 26, 2019
Mfg:
Shanghai United Imaging Healthcare Co., Ltd.
Mfg Country:
China
Recall ID:    85340
Product ID:    180561
Enforcement Date:    Apr 22, 2020
Last Published:    Apr 15, 2020

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Emert Number:    Z-1708-2020
Emert Status:    Announced