# FDA recall Z-2641-2020

> **Shanghai United Imaging Healthcare Co., Ltd.** · Class II · device recall initiated 2020-05-23.

## Product

Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036     Intended use The uCT Computed Tomography X-ray System uCT 530/uCT 550 is a computed tomography X-ray system intended 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 and vascular).

## Reason for recall

Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent scout scanning interruption due to occasional angle signal drift.. If these problems occur, it may be necessary to rescan the patient resulting in an additional dose of radiation and the possible need for additional contrast medium.

## Distribution

US Distribution to state of: TX

## Key facts

- **Recall number:** Z-2641-2020
- **Recalling firm:** Shanghai United Imaging Healthcare Co., Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-05-23
- **Report date:** 2020-07-29

- **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-2641-2020

## Citation

> AI Analytics. FDA recall Z-2641-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2641-2020. Source: US FDA. Licensed CC0.

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