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uMI recallZ-0223-2026 · 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-0223-2026
Status
Open, Classified
Initiated by the company
Sep 12, 2025
Posted by the FDA
Oct 21, 2025
Recalling firm
UIH Technologies LLC
Quantity
95 units
Product code
JAK
FDA submissions
K182237, K193241
Distribution
US: OUS:

Product description

Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 550 MD, Rx Only

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

UDI: (01)06971576832026/ Serial Numbers: 200017 200023 200024 200036 200045 200047 230002 230003 230004 230005 230006 230007 230008 230009 230011 230010 230012 230014 230013 200059 230015 230016 230017 230019 230020 230021 230022 230023 230024 230025 232001 200071 230026 230027 200072 230028 200074 230030 230029 200075 200076 230031 230032 230033 230034 230035 200079 200078 230037 230036 230038 230039 230040 230041 230042 230043 230044 230045 230047 230048 232002 202002 232003 232004 232005 230057 232006 232007 202004 232008 232009 202005 232010 202006 232011 202007 232012 232013 232014 230067 230068 230069 232015 232016 230070 230071 230073 202008 230072 230074 232017 202009 232018 232019 202010

Devices named in this recall

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

Product lines

Other devices under the same FDA submission

1 device cleared under K182237, K193241 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

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