Shanghai United Imaging Healthcare Co., Ltd.: Medical Device Recall in 2020 - (Recall #: Z-2522-2020)

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:

uCT 760 System, Computed Tomography X-ray System

Product Classification:

Class II

Date Initiated: May 8, 2020

Date Posted: July 15, 2020

Recall Number: Z-2522-2020

Event ID: 85804

Reason for Recall:

Two issues were identified with the computed tomography x-ray system including an intermittent issue which may affect image data leading to artifacts; and intermittent scout scanning interruption due to occasional angle signal drift. This may result in the need for rescanning of the patient with the patient receiving an additional dose of radiation and possible use of additional contrast media.

Status: Terminated

Product Quantity: 5 units

Code Information:

Model uCT 760; Serial Numbers: 600229, 600230, 600232, 600271 with software version R001.11.0.729741-Re-1100, and serial number 600282 with software version R001.11.0.785930-Re-1150.

Distribution Pattern:

Distributed to two customers. Both customers located in Houston, Texas.

Voluntary or Mandated:

Voluntary: Firm initiated