Shanghai United Imaging Healthcare Co., Ltd. recall (Class II): Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with software
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. Product: Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with software
- Published by source
- 2026-10-07
- First seen by Reality Radar
- 2026-10-20
- Last verified
- 2026-10-20
Affected
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
- Products
- Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with software
Whether your exact unit is affected depends on the model, serial number and region in the official notice.
What the official notice says
Risk: Class II: 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.
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Sources
- openFDA Recall Enforcement Reports Tier A · official published 2026-10-07
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