FDA Device recall Z-0225-2026
Shanghai United Imaging Healthcare Co., Ltd
- FDA Device
- Class II
- ongoing
- Published 2025-10-29
On 2025-10-29 the FDA classified a Class II recall of Shanghai United Imaging Healthcare Co., Ltd by Uih Technologies, citing third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0225-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-12 |
| Published | 2025-10-29 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Uih Technologies |
| Distribution | n/a |
Product
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI Panorama 35 MD, Rx Only
Reason
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Identifiers
| code_info | UDI: (01)06971576832170/ Serial numbers: 11MI410003, 11MI410004, 11MI410005, 20MI410001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0225-2026%22
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