Shanghai United Imaging Healthcare Co., Ltd.: Medical Device Recall in 2020 - (Recall #: Z-0448-2021)

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:

Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.

Product Classification:

Class II

Date Initiated: August 5, 2020

Date Posted: November 18, 2020

Recall Number: Z-0448-2021

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: 9

Code Information:

Serial Numbers: 200017, 200023, 200024, 200036, 200045, 200047, 230002, 230003, 230004

Distribution Pattern:

US Nationwide distribution including in the state of TX.

Voluntary or Mandated:

Voluntary: Firm initiated