Shanghai United Imaging Healthcare Co., Ltd.: Medical Device Recall in 2020 - (Recall #: Z-0446-2021)

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, Rx, CE, GTIN: 06971576831036 - Product Usage: ntended 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, vascular).

Product Classification:

Class II

Date Initiated: August 5, 2020

Date Posted: November 18, 2020

Recall Number: Z-0446-2021

Event ID: 86269

Reason for Recall:

A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.

Status: Ongoing

Product Quantity: 5

Code Information:

Serial Numbers: 353020, 353021, 353023, 353045, 353049

Distribution Pattern:

US Nationwide distribution including in the state of TX.

Voluntary or Mandated:

Voluntary: Firm initiated