Shanghai United Imaging Healthcare Co., Ltd.: Medical Device Recall in 2020 - (Recall #: Z-2521-2020)

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:

uDR 596i Digital Medical X-Ray Imaging System - Product Usage: intended to use by a qualified/ trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk.

Product Classification:

Class II

Date Initiated: February 27, 2020

Date Posted: July 15, 2020

Recall Number: Z-2521-2020

Event ID: 85196

Reason for Recall:

Two issues were identified with the stationary x-ray system. 1. Some position illustrations in the patient exam interface show the incorrect anatomical position for the standard of care. When the image is acquired with the wrong reference position, clinical diagnostic requirements cannot be met.T2. Where image stitching is used, the left and right tag information may be lost. When these problems are encountered, an additional exposure is needed and the patient will receive more radiation.

Status: Terminated

Product Quantity: 6 units

Code Information:

Model Number uDR 596i with software versions R002.19.0-1.8402-690106 and R002.19.0.8648.690112. Serial numbers: 270012, 270013, 270014, 270015, 270016 and 270017. UDI numbers: (01)06971576833023(240)88000093(21)270012; (01)06971576833023(240)88000093(21)270013; (01)06971576833023(240)88000093(21)270014; (01)06971576833023(240)88000093(21)270015; XXX; and XXX.

Distribution Pattern:

US Nationwide distribution including in the state of Texas.

Voluntary or Mandated:

Voluntary: Firm initiated