Shanghai United Imaging Healthcare Co., Ltd.: Medical Device Recall in 2020 - (Recall #: Z-2641-2020)

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:

Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 Intended use The uCT Computed Tomography X-ray System uCT 530/uCT 550 is a computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck and vascular).

Product Classification:

Class II

Date Initiated: May 23, 2020

Date Posted: July 29, 2020

Recall Number: Z-2641-2020

Event ID: 85771

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: 3

Code Information:

Serial Numbers: 353020, 353021, and 353023 with software version R001.11.0.729741-Re-1100

Distribution Pattern:

US Distribution to state of: TX

Voluntary or Mandated:

Voluntary: Firm initiated