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U.S. Department of Health and Human Services

Class 2 Device Recall uCT 550

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 Class 2 Device Recall uCT 550see related information
Date Initiated by FirmSeptember 12, 2025
Date PostedOctober 21, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0218-2026
Recall Event ID 97668
510(K)NumberK181414 K200016 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductShanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 550 MD, Rx Only
Code Information UDI:(01)06971576831036/ Serial Numbers: 353020 353021 353023 353045 353049 354001 354002 354003 354004 354005 354006 354007 354008 354009 354010 354011 354012 354013 354014 354015 354016 354017
Recalling Firm/
Manufacturer		 UIH Technologies LLC
9380 Kirby Dr
Houston TX 77054-2515
For Additional Information ContactCustomer Service
832-669-2799
Manufacturer Reason
for Recall		Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
FDA Determined
Cause 2		Other
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 adverse events: if any adverse events or quality issue occur, please report them to the FDA via the MedWatch program. 5. Please share this information with all relevant personnel at your facility, including technologist, service staff, and clinical teams.
Quantity in Commerce22 units
DistributionUS: OUS:
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JAK
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