uMIRecalls & reported problems across all models

We found 7 models of uMI by Shanghai United Imaging Healthcare Co., Ltd. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Aug 18, 2024 and Aug 18, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Smoking” (1 report).

13 FDA recall records name at least one of these models by its device identifier, 12 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

uMI recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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-3288-2026 · Root cause: Software design · Recall details · FDA record ↗

2. 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-3287-2026 · Root cause: Software design · Recall details · FDA record ↗

3. 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-3286-2026 · Root cause: Software design · Recall details · FDA record ↗

4. 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-3285-2026 · Root cause: Software design · Recall details · FDA record ↗

5. 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 ↗

6. 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-3283-2026 · Root cause: Software design · Recall details · FDA record ↗

7. 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 ↗

8. Sep 12, 2025Open, Classified

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

   Z-0224-2026 · Root cause: Other · Recall details · FDA record ↗

9. Sep 12, 2025Open, Classified

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

   Z-0223-2026 · Root cause: Other · Recall details · FDA record ↗

10. Mar 1, 2023Open, Classified

    Due to a software issue where the process of patient scanning, the scatter correction may occasionally fail with will potentially cause a failure of the PET image reconstruction and generation of PET images.

    Z-1353-2023 · Root cause: Software design · names 2 of these models · Recall details · FDA record ↗

11. May 30, 2022Open, Classified

    The wireless VSM module of a mobile PET/CT system, operating in an environment with strong Wi-Fi signals, may experience ECG signal and respiratory signal loss due to Wi-Fi interference. ECG and respiratory signal loss during acquisition can result in the failure of ECG and respiratory-gated reconstruction of the PET scan, which may require rescanning of the patient.

    Z-0087-2023 · Root cause: Device Design · Recall details · FDA record ↗

12. Aug 2, 2021Open, Classified

    The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.

    Z-2593-2021 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗

13. Mar 26, 2020Terminated

    In affected software version, of Positron emission tomography and computed tomography system, the CT Hounsfield unit curve may not display in real time when using the bolus tracking protocol with the tracker scan function. If this occurs, the subsequent clinical scanning protocols will need to be started manually, which may effect image enhancement, and may result in patient rescan.

    Z-2819-2020 · Root cause: Software design · Recall details · FDA record ↗

Most reported uMI problems

uMI models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• uMI uMI 550

  System, Tomography, Computed, Emission
  6 recalls0 reports
• uMI uMI 550

  System, Tomography, Computed, Emission
  2 recalls1 report
• uMI uMI 780

  System, X-Ray, Tomography, Computed
  2 recalls0 reports
• uMI uMI Panorama 35

  System, Tomography, Computed, Emission
  2 recalls0 reports
• uMI uMI Panorama GS

  System, Tomography, Computed, Emission
  1 recall0 reports
• uMI uMI Panvivo

  System, Tomography, Computed, Emission
  1 recall0 reports
• uMI uMI Panvivo S

  System, Tomography, Computed, Emission
  1 recall0 reports

Recent uMI adverse event reports

The 1 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2024Smoking; Smoking

  07:15 AM OF J(B)(6)2024, UIHS CALL CENTER RECEIVED CALL ABOUT PET COOLING ERRORS, UIHS CALL CENTER CSE WORKED WITH SITE TO SHUT DOWN SYSTEM TO RECOVER THE ERROR 2 TIMES WITH FULL POWER OFF. 09:20 AM, LOCAL CSE ARRIVED AT THE SITE FOR DISPATCH. WHEN CSE ARRIVED, HE NOTICED A STRONG SMELL OF ELECTRICAL OZONE AND THE SYSTEM WAS ON. CSE FOUND THAT KC1 RELAY CABLE ASSY WAS CHARRED. THE HALON GAS FIRE SUPPRESSION WAS DEPLOYED. THERE IS NO DISCOLORATION AND DISTORTION ON THE COVER. THERE WAS NO ONE INJURED DUE TO THIS FAILURE. LOCAL CSE CHECKED SYSTEM FAILURE PARTS AND REPLACED WITH SPARE PARTS, AND PASSED QUALITY CHECK ON JULY 3RD,2024. SYSTEM HAS BEEN DELIVERED TO CUSTOMER NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19999027 ↗

Other Shanghai United Imaging Healthcare Co., Ltd. products

• uCT6 models · 0 reports · 12 recalls