ClearanceBrief
Recall Z-0219-2026 ยท JAK System, X-Ray, Tomography, Computed

UIH Technologies LLC

Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 760 MD, Rx Only

DateOct 21, 2025 (initiated Sep 12, 2025)
StatusOpen, Classified
ReasonThird-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Root causeOther
ActionOn 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
Quantity11 units
DistributionUS: OUS:
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K172135uCT Computed Tomography X-ray System
Shanghai United Imaging Healthcare Co., Ltd., Mar 2, 2018
K230162uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis
Shanghai United Imaging Healthcare Co., Ltd., Aug 1, 2023