Recall Z-0087-2023 ยท KPS System, Tomography, Computed, Emission
Shanghai United Imaging Healthcare Co., Ltd.
Positron Emission Tomography and Computed Tomography System, Model: uMI 550
| Date | Oct 13, 2022 (initiated May 30, 2022) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | On 5/30/22, advisory notices were emailed to customers who were asked to do the following: If the connection is not stable, perform a system reboot immediately and observe if the ECG and respiratory signals are restored. 2. If a system reboot cannot restore the wireless connection, use a third-party trigger device that supports 50ohm BNC interface and TTL output pulse with 100ms width, and connect to the system's external trigger port on the front cover. The port can be located according to Section 3.4.7 of the System Operator Manual. a) Make sure ECG and respiratory square pulse signals are |
| Quantity | 32 |
| Distribution | Distribution to US states of TX, WI, CA, and MI |
| FDA record | Open on fda.gov |