FDA-Device2023-04-19Class II
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057
Shanghai United Imaging Healthcare Co., Ltd.
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.
Sold states
U.S. Nationwide distribution in the state of TX. O.U.S.: Not provided.
Affected count
47 systems (U.S. only)
Manufactured in
No. 2258 Chengbei Rd, Jiading Ind., N/A, Shanghai, N/A, China
Products
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1353-2023Don't want to check this manually?
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