# FDA recall Z-1160-2021

> **Shanghai United Imaging Healthcare Co., Ltd.** · Class II · device recall initiated 2021-01-25.

## Product

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.

## 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.

## Distribution

US Nationwide distribution in the state of TX.

## Key facts

- **Recall number:** Z-1160-2021
- **Recalling firm:** Shanghai United Imaging Healthcare Co., Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-01-25
- **Report date:** 2021-03-10
- **Termination date:** 2022-05-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Shanghai, China

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1160-2021

## Citation

> AI Analytics. FDA recall Z-1160-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1160-2021. Source: US FDA. Licensed CC0.

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