Positron Emission Tomography and Computed Tomography System — Class II medical device recall Z-0087-2023
Ongoing recall by Shanghai United Imaging Healthcare Co., Ltd., reported 2022-10-19, distributed in CA, MI, TX, WI. The wireless VSM module of a mobile PET/CT system, operating in an environment with strong Wi-Fi signals, may
| Recall number | Z-0087-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Shanghai United Imaging Healthcare Co., Ltd., Shanghai, N/A, China |
| Recall initiated | 2022-05-30 |
| Classified | 2022-10-13 |
| Reported by FDA | 2022-10-19 |
| Distributed | CA, MI, TX, WI |
| Quantity | 32 |
| UPC / GTIN / UDI-DI | 06971576832026 |
| Serial numbers | 06971576832026/230002, 230003, 230004, 230005, 230006, 230007, 230008, 230009, 230010, 230011, 230012, 230013, 230014, 230015, 230016, 230017, 230019, 230020, 230021, 230022, 230023, 230024, 230025, 230026, 230027 and 7 more |
| Model numbers | 550 |
Product
Positron Emission Tomography and Computed Tomography System, Model: uMI 550
Reason for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.