# FDA recall Z-2593-2021

> **Shanghai United Imaging Healthcare Co., Ltd.** · Class II · device recall initiated 2021-08-02.

## Product

uMI 550 System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.

## Reason for recall

The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.

## Distribution

U.S. Nationwide distribution in the states of CA, IL, IN, TX, and WI.

## Key facts

- **Recall number:** Z-2593-2021
- **Recalling firm:** Shanghai United Imaging Healthcare Co., Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-08-02
- **Report date:** 2021-10-06

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2593-2021

## Citation

> AI Analytics. FDA recall Z-2593-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2593-2021. Source: US FDA. Licensed CC0.

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