# FDA recall Z-0446-2021

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

## Product

Computed Tomography X-Ray System, Model uCT 550, Rx, CE, GTIN:  06971576831036 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).

## 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-0446-2021
- **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-0446-2021

## Citation

> AI Analytics. FDA recall Z-0446-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0446-2021. Source: US FDA. Licensed CC0.

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