# FDA recall Z-2705-2020

> **Shanghai United Imaging Healthcare Co., Ltd.** · Class II · device recall initiated 2020-06-20.

## Product

Computed Tomography X-ray System; Model uCT 550; Rx;  UDI: (01) GTIN: 06971576831036 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and vascular).

## Reason for recall

The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.

## Distribution

US Nationwide distribution including in the states of CA, IN and TX. See uploaded distribution list for more details.

## Key facts

- **Recall number:** Z-2705-2020
- **Recalling firm:** Shanghai United Imaging Healthcare Co., Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-06-20
- **Report date:** 2020-08-05

- **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-2705-2020

## Citation

> AI Analytics. FDA recall Z-2705-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2705-2020. Source: US FDA. Licensed CC0.

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