Shanghai United Imaging Healthcare Co., Ltd.: Medical Device Recall in 2021 - (Recall #: Z-1160-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended to used 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. Not for mammography.

Product Classification:

Class II

Date Initiated: January 25, 2021

Date Posted: March 10, 2021

Recall Number: Z-1160-2021

Event ID: 87289

Reason for Recall:

There is a potential for the X-Ray tube head (Touch screen interface) to perform an uncommanded motion. This could result in a collision with the patient.

Status: Terminated

Product Quantity: 6 units

Code Information:

Serial Number: 270012, 270013, 270014, 270015, 270016, 270017

Distribution Pattern:

US Nationwide distribution in the state of TX.

Voluntary or Mandated:

Voluntary: Firm initiated