uCTRecalls & reported problems across all models

We found 6 models of uCT by Shanghai United Imaging Healthcare Co., Ltd. in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.

12 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

uCT 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-3282-2026 · 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-3281-2026 · 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-3280-2026 · 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-3279-2026 · 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-3278-2026 · 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-3277-2026 · 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-0221-2026 · 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-0220-2026 · 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-0219-2026 · Root cause: Other · Recall details · FDA record ↗

10. Sep 12, 2025Open, Classified

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

    Z-0218-2026 · Root cause: Other · Recall details · FDA record ↗

11. Sep 12, 2025Open, Classified

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

    Z-0217-2026 · Root cause: Other · Recall details · FDA record ↗

12. May 8, 2020Open, Classified

    Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent scout scanning interruption due to occasional angle signal drift.. If these problems occur, it may be necessary to rescan the patient resulting in an additional dose of radiation and the possible need for additional contrast medium.

    Z-2472-2020 · Root cause: Software design · Recall details · FDA record ↗

uCT models

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

• uCT uCT 530

  System, X-Ray, Tomography, Computed
  3 recalls0 reports
• uCT uCT 550

  System, X-Ray, Tomography, Computed
  2 recalls0 reports
• uCT uCT 760

  System, X-Ray, Tomography, Computed
  2 recalls0 reports
• uCT uCT 780

  System, X-Ray, Tomography, Computed
  2 recalls0 reports
• uCT uCT ATLAS

  System, X-Ray, Tomography, Computed
  2 recalls0 reports
• uCT uCT ATLAS Astound

  System, X-Ray, Tomography, Computed
  1 recall0 reports

Other Shanghai United Imaging Healthcare Co., Ltd. products

• uMI7 models · 1 reports · 13 recalls