FDA recall Z-0087-2023

Shanghai United Imaging Healthcare Co., Ltd. · Class II · device

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.

Distribution

Distribution to US states of TX, WI, CA, and MI

Key facts

Status: Ongoing
Initiation date: 2022-05-30
Report date: 2022-10-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Shanghai, N/A, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0087-2023