Shanghai United Imaging Healthcare Co., Ltd.: Medical Device Recall in 2020 - (Recall #: Z-2705-2020)

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; Rx; UDI: (01) GTIN: 06971576831036 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and vascular).

Product Classification:

Class II

Date Initiated: June 20, 2020

Date Posted: August 5, 2020

Recall Number: Z-2705-2020

Event ID: 85868

Reason for Recall:

The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.

Status: Ongoing

Product Quantity: 3

Code Information:

SN 353020, 353021, 353023

Distribution Pattern:

US Nationwide distribution including in the states of CA, IN and TX. See uploaded distribution list for more details.

Voluntary or Mandated:

Voluntary: Firm initiated