FDA-Device2022-10-19Class II
Positron Emission Tomography and Computed Tomography System, Model: uMI 550
Shanghai United Imaging Healthcare Co., Ltd.
Hazard
The wireless VSM module of a mobile PET/CT system, operating in an environment with strong Wi-Fi signals, may experience ECG signal and respiratory signal loss due to Wi-Fi interference. ECG and respiratory signal loss during acquisition can result in the failure of ECG and respiratory-gated reconstruction of the PET scan, which may require rescanning of the patient.
Sold states
Distribution to US states of TX, WI, CA, and MI
Affected count
32
Manufactured in
No. 2258 Chengbei Rd, Jiading Ind., N/A, Shanghai, N/A, China
Products
Positron Emission Tomography and Computed Tomography System, Model: uMI 550
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0087-2023Don't want to check this manually?
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