# FDA recall Z-2819-2020

> **Shanghai United Imaging Healthcare Co., Ltd.** · Class II · device recall initiated 2020-03-26.

## Product

Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - 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

In affected software version, of Positron emission tomography and computed tomography system, the CT Hounsfield unit curve may not display in real time when using the bolus tracking protocol with the tracker scan function. If this occurs, the subsequent clinical scanning protocols will need to be started manually, which may effect image enhancement, and may result in patient rescan.

## Distribution

US Nationwide distribution including in the state of TX.

## Key facts

- **Recall number:** Z-2819-2020
- **Recalling firm:** Shanghai United Imaging Healthcare Co., Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-03-26
- **Report date:** 2020-08-26
- **Termination date:** 2023-08-02

- **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-2819-2020

## Citation

> AI Analytics. FDA recall Z-2819-2020. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/Z-2819-2020. Source: US FDA. Licensed CC0.

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