Skip to content

uMI recallZ-3284-2026 · Shanghai United Imaging Healthcare Co., Ltd. · initiated Aug 11, 2026

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 Shanghai United Imaging Healthcare Co., Ltd. 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

Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.

FDA root cause category: Software design

What the company is doing

On 8/11/2026, correction notices were emailed to customers informing them that software will be released to resolve the software problem. Customers were asked to do the following: When using the Study Split function, follow the requirements below: 1) Temporarily disable the "Study Split" function. Navigate to the system configuration interface and uncheck the "Auto Study Split" option. 2) If the "Study Split" function is clinically necessary, open the system configuration interface and select "Split on PACS" instead of "Split on Local". 3) When "Auto study split" is checked, ensure that PACS (Picture Archiving and Communication System) is configured on site and auto-archive is enabled. 4) If images are found to be missing on the PA interface, immediately verify whether the corresponding image data exists in the PACS. a) If images exist in PACS: They can be retrieved from PACS for review. b) If images do not exist in PACS: Contact the firm's service engineer for assistance. For further questions, contact firm service engineer or call firm Customer Contact Center at (855) 221-1552 or 832-699-2799

Recall details

Recall number
Z-3284-2026
Status
Open, Classified
Initiated by the company
Aug 11, 2026
Posted by the FDA
Sep 25, 2026
Recalling firm
Shanghai United Imaging Healthcare Co., Ltd.
Quantity
7
Product code
KPS
FDA submissions
K223325, K232712
Distribution
US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID, LA, MT, FL, CO, IN, KY, AL, OH, MI, IA, MO, NY, NV, TN, WV, SC, WI, IL, MS, MA, NJ.

Product description

Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with software

Code information (models, lots, serial numbers)

UDI-DI: 06971576832170. Serial Number: 11MI410003/R001.19.4.1909524, 11MI410004/R001.19.4.1909524, 11MI410005/R001.19.4.1909524, 20MI410001/R001.19.4.1909524, 20MI410002/R001.19.4.1909524, 20MI410003/R001.21.0.1993334, 20MI410004/R001.19.4.1909524

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 99731).

Sources and updates

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