# FDA recall Z-2521-2020

> **Shanghai United Imaging Healthcare Co., Ltd.** · Class II · device recall initiated 2020-02-27.

## Product

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.

## 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.

## Distribution

US Nationwide distribution including in the state of Texas.

## Key facts

- **Recall number:** Z-2521-2020
- **Recalling firm:** Shanghai United Imaging Healthcare Co., Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-02-27
- **Report date:** 2020-07-15
- **Termination date:** 2021-05-28

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2521-2020

## Citation

> AI Analytics. FDA recall Z-2521-2020. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2521-2020. Source: US FDA. Licensed CC0.

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