Shanghai United Imaging Healthcare Co., Ltd.: Medical Device Recall in 2022 - (Recall #: Z-1075-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h

Product Classification:

Class II

Date Initiated: July 30, 2019

Date Posted: May 18, 2022

Recall Number: Z-1075-2022

Event ID: 90104

Reason for Recall:

X-ray imaging system positioning image and protocol label is reversed for Flexion and Extension on C-Spine and L-Spine, this will cause the image to be incorrectly labeled and may cause the patient to have a repeat exposure.

Status: Terminated

Product Quantity: 4

Code Information:

DI/GTIN: 06971576833023, Serial Numbers: 270012, 270013,270014, 270015

Distribution Pattern:

US Nationwide distribution in the state of TX.

Voluntary or Mandated:

Voluntary: Firm initiated