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RecallWatchMedical Device Safety
Class IIOngoingZ-0218-2026

UIH Technologies LLC recalls Shanghai United Imaging Healthcare Co.

UIH Technologies LLCHouston, TX, United StatesReported Oct 29, 2025 · 8 months ago
Legal News Analyst ·

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 550 MD, Rx OnlyUDI
    22 affected lots
    353020353021353023353045353049354001354002354003
    +14 more354004354005354006354007354008354009354010354011354012354013354014354015354016354017

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 details

US: OUS:

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Taylor Coteus
Legal News Analyst

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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