The Recall Desk
ModerateFDA (Devices)·Z-3283-2026·Announced 2026-10-07

United Imaging uMI 550 PET/CT Systems Recalled for Software Defect

FDA is recalling 34 United Imaging uMI 550 PET/CT systems due to a software issue that can 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, and the source text does not report any injuries, illnesses, or deaths, only the potential need for rescans, which aligns with the Moderate severity criteria for low-risk or precautionary issues.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling 34 units of the Positron Emission Tomography and Computed Tomography System, Model uMI 550, manufactured by Shanghai United Imaging Healthcare Co., Ltd. The recall is due to a software defect that occurs when the Split or Local function is enabled and multiple RIS exams are merged into a single study.

This software problem prevents patient images from being visible on the Patient Administration interface. As a result, healthcare providers may be unable to view the necessary images, which may lead to the need for patient 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.

Healthcare facilities should contact Shanghai United Imaging Healthcare Co., Ltd. for further instructions on how to resolve the software issue. The FDA has classified this as a Class II recall, indicating that the defect may cause temporary or medically reversible health consequences.

The recalled product

Product
Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with software
Manufacturer
Shanghai United Imaging Healthcare Co., Ltd.
Category
Medical Device — Imaging Equipment
Hazard
Affected units
34

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 (20)

  • UDI-DI: 06971576832026. Serial Number/Software: 200045/R001.19.0.1812568
  • 200163/R001.19.3.2011750
  • 200164/R001.18.0.1683822
  • 200165/R001.18.0.1683822
  • 200166/R001.18.0.1683822
  • 200167/R001.18.0.1683822
  • 202009/R001.19.3.2011750
  • 202016/R001.19.0.1812568
  • 202018/R001.19.0.1812568
  • 202019/R001.19.0.1812568
  • 202020/R001.19.1.1929746
  • 202021/R001.19.1.1929746
  • 202022/R001.19.1.1929746
  • 230040/R001.19.3.2011750
  • 230048/R001.19.0.1812568
  • 230106/R001.19.0.1812568
  • 232038/R001.19.0.1812568
  • 232039/R001.19.0.1812568
  • 232040/R001.19.0.1812568
  • 232041/R001.19.0.1812568

Distribution

Distributed nationwide across the United States.

The notice also names 29 states specifically:

Related recalls

Same manufacturer · Shanghai United Imaging Healthcare Co., Ltd.

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