# FDA recall Z-2472-2020

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

## Product

uCT 530 Computed Tomography X-Ray System

## 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

Distributed to Texas.

## Key facts

- **Recall number:** Z-2472-2020
- **Recalling firm:** Shanghai United Imaging Healthcare Co., Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-05-08
- **Report date:** 2020-07-08

- **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-2472-2020

## Citation

> AI Analytics. FDA recall Z-2472-2020. Retrieved 2026-06-13 from https://api.ai-analytics.org/recall/Z-2472-2020. Source: US FDA. Licensed CC0.

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