Drug recall
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT)…
FDA recall event 91870 · Class II · Shanghai United Imaging Healthcare Co., Ltd.
Key facts
| Event ID | 91870 |
|---|---|
| Recall numbers | Z-1353-2023 |
| Recalling firm | Shanghai United Imaging Healthcare Co., Ltd. |
| Product type | Devices |
| Products | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Mar 1, 2023 |
| Report date | Apr 19, 2023 |
| City | Shanghai |
| Country | China |
| FEI number | 3011015597 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: