# FDA recall Z-1353-2023

> **Shanghai United Imaging Healthcare Co., Ltd.** · Class II · device recall initiated 2023-03-01.

## Product

Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550  Part Number:  88000657  88000057

## Reason for recall

Due to a software issue where the process of patient scanning, the scatter correction may occasionally fail with will potentially cause a failure of the PET image reconstruction and generation of PET images.

## Distribution

U.S. Nationwide distribution in the state of TX.  O.U.S.: Not provided.

## Key facts

- **Recall number:** Z-1353-2023
- **Recalling firm:** Shanghai United Imaging Healthcare Co., Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-03-01
- **Report date:** 2023-04-19

- **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-1353-2023

## Citation

> AI Analytics. FDA recall Z-1353-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1353-2023. Source: US FDA. Licensed CC0.

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