Class II — Shanghai United Imaging Healthcare Co., Ltd.
| Recalling firm | Shanghai United Imaging Healthcare Co.,Ltd. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057 |
| Quantity | 47 systems (U.S. only) |
| Distribution | U.S. Nationwide distribution in the state of TX. O.U.S.: Not provided. |
| Initiated | 2023-03-01 |
| Classified | 2023-04-07 |
| Recall number | Z-1353-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Shanghai United Imaging Healthcare Co., Ltd. (Z-1353-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91870/
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