Reported Oct 19, 2022 · Ongoing
Positron Emission Tomography and Computed Tomography System, Model: uMI 550
Shanghai United Imaging Healthcare Co., Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Shanghai United Imaging Healthcare Co., Ltd. · No. 2258 Chengbei Rd, Jiading Ind. · Shanghai, N/A · N/A
Is this the product you have?
- Positron Emission Tomography and Computed Tomography System
- ModeluMI 550
- Lot codes and dates
- UDI-DI/Serial Numbers
06971576832026/230002230003230004230005230006230007230008230009230010230011230012230013230014230015230016230017230019230020230021230022230023230024230025230026230027230028230029230030230031230032230033232001
- UDI-DI/Serial Numbers
- Amount recalled
- 32
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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