Shanghai United Imaging Healthcare Co., Ltd.: Medical Device Recall in 2022 - (Recall #: Z-0087-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Positron Emission Tomography and Computed Tomography System, Model: uMI 550

Product Classification:

Class II

Date Initiated: May 30, 2022

Date Posted: October 19, 2022

Recall Number: Z-0087-2023

Event ID: 90888

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.

Status: Ongoing

Product Quantity: 32

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated