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Shanghai United Imaging Healthcare Co., Ltd. recalls Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI
Recalled April 19, 2023 · FDA recall Z-1353-2023 · Shanghai United Imaging Healthcare
Hazard
Due to a software issue where the process of patient scanning, the scatter correction may occasionally fail with will potentially cause a failure of the PET image reconstruction and generation of PET images. · FDA Class II
Units
47 systems (U.S. only)
Sold at
U.S. Nationwide distribution in the state of TX. O.U.S.: Not provided.
Description
Due to a software issue where the process of patient scanning, the scatter correction may occasionally fail with will potentially cause a failure of the PET image reconstruction and generation of PET images.
Product
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057
Manufacturer(s)
Shanghai United Imaging Healthcare Co., Ltd.
Made in
China
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →