Shanghai United Imaging Healthcare Co., Ltd.: Medical Device Recall in 2020 - (Recall #: Z-2472-2020)

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 530 Computed Tomography X-Ray System

Product Classification:

Class II

Date Initiated: May 8, 2020

Date Posted: July 8, 2020

Recall Number: Z-2472-2020

Event ID: 85809

Reason for Recall:

Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent scout scanning interruption due to occasional angle signal drift.. If these problems occur, it may be necessary to rescan the patient resulting in an additional dose of radiation and the possible need for additional contrast medium.

Status: Ongoing

Product Quantity: 4 units

Code Information:

Units with software version no. R001.11.0.729741-Re-1100 including the following: Serial number/GTIN: 300162 (GTIN: 6971576831012); 300163 (GTIN: 6971576831012); 300174 (GTIN: 6971576831012); and 300176 (GTIN: 6971576831012).

Distribution Pattern:

Distributed to Texas.

Voluntary or Mandated:

Voluntary: Firm initiated