Shanghai United Imaging Healthcare Co — Class II medical device recall Z-1353-2023
Ongoing recall by Shanghai United Imaging Healthcare Co., Ltd., reported 2023-04-19, distributed nationwide. Due to a software issue where the process of patient scanning, the scatter correction may occasionally fail wi
| Recall number | Z-1353-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Shanghai United Imaging Healthcare Co., Ltd., Shanghai, N/A, China |
| Recall initiated | 2023-03-01 |
| Classified | 2023-04-07 |
| Reported by FDA | 2023-04-19 |
| Distributed | Nationwide (US) |
| Quantity | 47 systems |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 06971576832026, 06971576832057 |
| Model numbers | 550, 88000057, 88000657 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1353-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.