# FDA recall Z-1708-2020

> **Shanghai United Imaging Healthcare Co., Ltd.** · Class II · device recall initiated 2019-08-26.

## Product

Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx Only, CE 0197,  UDI: (01)06971576832026 - Product Usage: This system is 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

Potential sporadic software bugs in R001.3.0.0.750505 software version may cause an issue with the PET acquisition raw data causing reconstruction problems during PET/CT scanning and could possibly cause rescans of patients with additional dose.

## Distribution

US Nationwide distribution in the state TX.

## Key facts

- **Recall number:** Z-1708-2020
- **Recalling firm:** Shanghai United Imaging Healthcare Co., Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-08-26
- **Report date:** 2020-04-22
- **Termination date:** 2022-05-18

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1708-2020

## Citation

> AI Analytics. FDA recall Z-1708-2020. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-1708-2020. Source: US FDA. Licensed CC0.

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