Shanghai United Imaging Healthcare Co., Ltd.: Medical Device Recall in 2020 - (Recall #: Z-1708-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx Only, CE 0197, UDI: (01)06971576832026 - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.

Product Classification:

Class II

Date Initiated: August 26, 2019

Date Posted: April 22, 2020

Recall Number: Z-1708-2020

Event ID: 85340

Reason for Recall:

Potential sporadic software bugs in R001.3.0.0.750505 software version may cause an issue with the PET acquisition raw data causing reconstruction problems during PET/CT scanning and could possibly cause rescans of patients with additional dose.

Status: Terminated

Product Quantity: 2 units

Code Information:

Serial Numbers: 200017 and 200023

Distribution Pattern:

US Nationwide distribution in the state TX.

Voluntary or Mandated:

Voluntary: Firm initiated