UIH Technologies LLC recalls Shanghai United Imaging Healthcare Co.
Reason for recall
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 760 MD, Rx OnlyUDI11 affected lots600229600232600271600282604001604002604003604004
+3 more
604005604006604008
What the firm is doing
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 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.
DistributionShow detailsHide
US: OUS:
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0219-2026
- FDA 510(k) clearance · K172135The device's official FDA premarket clearance record
- FDA 510(k) clearance · K230162The device's official FDA premarket clearance record
- FDA device classification · JAKOfficial FDA classification for this device type
- CFR regulation · 21 CFR 892.1750The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find UIH Technologies LLCSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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