Shanghai United Imaging Healthcare Co., Ltd.: Medical Device Recall in 2020 - (Recall #: Z-2819-2020)

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 Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - 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: March 26, 2020

Date Posted: August 26, 2020

Recall Number: Z-2819-2020

Event ID: 85453

Reason for Recall:

In affected software version, of Positron emission tomography and computed tomography system, the CT Hounsfield unit curve may not display in real time when using the bolus tracking protocol with the tracker scan function. If this occurs, the subsequent clinical scanning protocols will need to be started manually, which may effect image enhancement, and may result in patient rescan.

Status: Terminated

Product Quantity: 3

Code Information:

UDI: 06971576832026, Software Version: R001.3.0.0.750505, Serial Numbers: 200017, 200023, 200024

Distribution Pattern:

US Nationwide distribution including in the state of TX.

Voluntary or Mandated:

Voluntary: Firm initiated