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uMI uMI Panorama 35Recalls & reported problems

Shanghai United Imaging Healthcare Co., Ltd. · Positron Emission Tomography and Computed Tomography System · Class 2

All models of uMI (7)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
2

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

2 FDA recall records name this device's identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

  1. Aug 11, 2026Open, Classified

    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.

    Z-3284-2026 · Root cause: Software design · Recall details · FDA record ↗

  2. Sep 12, 2025Open, Classified

    Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

    Z-0225-2026 · Root cause: Other · Recall details · FDA record ↗

Other System, Tomography, Computed, Emission devices

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Sources and updates

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