Recall Z-0224-2026 ยท JAK System, X-Ray, Tomography, Computed
UIH Technologies LLC
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 780 MD, Rx Only
| Date | Oct 21, 2025 (initiated Sep 12, 2025) |
| Status | Open, Classified |
| Reason | Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement. |
| Root cause | Other |
| Action | On September 12, 2025, UIH Technologies LLC, issued a recall notification to affected consignees. UIH asked consignees to take the following actions: 1. Ensure patient positioning clearance: When positioning the patient, confirm that arms and legs and clear of all table gaps and moving parts. 2. Avoid use of third-party slickers: We advise against the use of any non-UIH-approved slickers. 3. Service Contact: For technical assistance, contact your United Imaging Service engineer or reach out to our 24/7 Customer Contact Center, Toll-Free: (855) 221-1552/Direct: (832) 699-2799 4.Report ad |
| Quantity | 3 units |
| Distribution | US: OUS: |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172143 | uMI 780 PET/CT System Shanghai United Imaging Healthcare Co., Ltd., Apr 13, 2018 |