# FDA recall Z-0448-2021

> **Shanghai United Imaging Healthcare Co., Ltd.** · Class II · device recall initiated 2020-08-05.

## Product

Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN:  06971576832026 - 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

A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during  multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.

## Distribution

US Nationwide distribution including in the state of TX.

## Key facts

- **Recall number:** Z-0448-2021
- **Recalling firm:** Shanghai United Imaging Healthcare Co., Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-08-05
- **Report date:** 2020-11-18

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0448-2021

## Citation

> AI Analytics. FDA recall Z-0448-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0448-2021. Source: US FDA. Licensed CC0.

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