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uMI recallZ-0224-2026 · UIH Technologies LLC · initiated Sep 12, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from UIH Technologies LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

FDA root cause category: Other

What the company 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.

Recall details

Recall number
Z-0224-2026
Status
Open, Classified
Initiated by the company
Sep 12, 2025
Posted by the FDA
Oct 21, 2025
Recalling firm
UIH Technologies LLC
Quantity
3 units
Product code
JAK
FDA submissions
K172143
Distribution
US: OUS:

Product description

Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 780 MD, Rx Only

Code information (models, lots, serial numbers)

UDI: (01)06971576832033/ Serial Number: 300072, 300082, 300098

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 97668).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page