Z-3285-2026

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

Name: Z-3285-2026 Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama GS with software
Creator: Shanghai United Imaging Healthcare Co., Ltd.
Published: 2026-08-11
License: https://open.fda.gov/license/

Shanghai United Imaging Healthcare Co., Ltd. / initiated 2026-08-11 / Open, Classified

FDA source

Recall record

Recall number: Z-3285-2026
Status: Open, Classified
Initiated: 2026-08-11
Posted: 2026-09-25
Recalling firm: Shanghai United Imaging Healthcare Co., Ltd.
Product: Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama GS with software
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: 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: Software design
Action: 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
Quantity in commerce: 3
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 codes and lots: UDI-DI: 06971576832187. Serial Number: 11MIP00007/R001.17.5.1785268, 11MIP00009/R001.18.2.1967222, 11MIP00010/R001.18.2.1967222

Product code KPS

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-29. View this recall on fda.gov (opens on fda.gov)