FDA Device recall Z-0087-2023
Positron Emission Tomography and Computed Tomography System, Model: uMI 550
- FDA Device
- Class II
- ongoing
- Published 2022-10-19
On 2022-10-19 the FDA classified a Class II recall of Positron Emission Tomography and Computed Tomography System, Model: uMI 550 by Shanghai United Imaging Healthcare, citing 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 interf….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0087-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-05-30 |
| Published | 2022-10-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Shanghai United Imaging Healthcare |
| Distribution | CA, MI, TX, WI |
Product
Positron Emission Tomography and Computed Tomography System, Model: uMI 550
Reason
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.
Identifiers
| code_info | UDI-DI/Serial Numbers: 06971576832026/230002, 230003, 230004, 230005, 230006, 230007, 230008, 230009, 230010, 230011, 2…UDI-DI/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, 230028, 230029, 230030, 230031, 230032, 230033, 232001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0087-2023%22
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