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
- 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 ↗
- 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
- uMI uMI 550Shanghai United Imaging Healthcare Co., Ltd. · System, Tomography, Computed, Emission6 recalls0 reports
- uMI uMI 550Shanghai United Imaging Healthcare Co., Ltd. · System, Tomography, Computed, Emission2 recalls1 report
- Discovery 670 PRO H3100AHG E Medical Systems Israel Ltd. · System, tomography, computed, emission2 recalls0 reports
- NMCT 860G E Medical Systems Israel Ltd. · System, tomography, computed, emission2 recalls0 reports
- NM 830G E Medical Systems Israel Ltd. · System, tomography, computed, emission1 recall1 report
- Vereos PET/CTPhilips Medical Systems Nederland B.V. · System, tomography, computed, emission1 recall1 report
- MyoSPECT H3912BCG E Medical Systems Israel Ltd. · System, tomography, computed, emission1 recall0 reports
- uMI uMI PanvivoShanghai United Imaging Healthcare Co., Ltd. · System, Tomography, Computed, Emission1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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