uCT uCT 760Recalls & reported problems

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.

5 other recalls cover devices cleared under the same FDA submission (K172135, K230162); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 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-3279-2026 · Root cause: Software design · 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-0219-2026 · Root cause: Other · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K172135, K230162. One submission often covers many models, so check the product and lot details in each record.

• Z-3280-2026 · Aug 11, 2026 · Open, Classified
  Computed Tomography X-ray System, Model: uCT 780 with software
• Z-0220-2026 · Sep 12, 2025 · Open, Classified
  Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 780 MD, Rx Only
• Z-0447-2021 · Aug 5, 2020 · Open, Classified
  Computed Tomography X-Ray System, Model uCT 760, Rx, CE, GTIN: 06971576831043 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of
• Z-2703-2020 · Jun 20, 2020 · Open, Classified
  Computed Tomography X-ray System; Model uCT 760; Rx; UDI: (01) GTIN: 06971576831043 - Product Usage: intended to produce cross-sectional images of the body using computer reconstr
• Z-2522-2020 · May 8, 2020 · Terminated
  uCT 760 System, Computed Tomography X-ray System