The Recall Desk
ModerateFDA (Devices)·Z-3287-2026·Announced 2026-10-07

United Imaging uMI Panvivo S PET/CT Systems Recalled for Software Defect

Shanghai United Imaging Healthcare is recalling six uMI Panvivo S PET/CT systems due to a software defect that may hide patient images, potentially requiring rescans.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or deaths. The primary risk is the need for rescans due to hidden images, which aligns with the criteria for a moderate severity score involving low-risk operational issues without reported harm.

Plain-English summary

Shanghai United Imaging Healthcare Co., Ltd. is recalling six units of the Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo S with software. The recall is due to a software problem that occurs when the Split or Local function is enabled and multiple RIS exams are merged into a single study.

This defect prevents patient images from being visible on the Patient Administration interface. As a result, patients may require rescans. The affected units were distributed nationwide 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, SC, WI, IL, MS, MA, and NJ.

The specific serial numbers and software versions affected are 11MI510005/R003.2.0.1872339, 20MI510001/R003.2.0.1872339, 20MI510002/R003.2.0.1872339, 20MI510003/R003.2.0.1872339, 20MI510004/R003.2.0.1872339, and 20MI510005/R003.2.0.1872339. The UDI-DI for the product is 06971576832255. Healthcare facilities should contact the recalling firm for instructions on how to resolve the software issue.

The recalled product

Product
Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo S with software
Manufacturer
Shanghai United Imaging Healthcare Co., Ltd.
Category
Medical Device — Imaging Equipment
Hazard
Affected units
6

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • UDI-DI: 06971576832255. Serial Number/Software: 11MI510005/R003.2.0.1872339
  • 20MI510001/R003.2.0.1872339
  • 20MI510002/R003.2.0.1872339
  • 20MI510003/R003.2.0.1872339
  • 20MI510004/R003.2.0.1872339
  • 20MI510005/R003.2.0.1872339

Distribution

Distributed nationwide across the United States.

The notice also names 29 states specifically:

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