uCT uCT 530Recalls & reported problems

Summary

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

3 FDA recall records name this device's identifier, 3 still open.

7 other recalls cover devices cleared under the same FDA submission (K181414, K200016); 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-3277-2026 · 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-0217-2026 · Root cause: Other · FDA record ↗

3. 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 · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K181414, K200016. One submission often covers many models, so check the product and lot details in each record.

• Z-3278-2026 · Aug 11, 2026 · Open, Classified
  Computed Tomography X-ray System, Model: uCT 550 with software
• Z-0218-2026 · Sep 12, 2025 · Open, Classified
  Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 550 MD, Rx Only
• Z-0446-2021 · Aug 5, 2020 · Open, Classified
  Computed Tomography X-Ray System, Model uCT 550, Rx, CE, GTIN: 06971576831036 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of
• Z-0445-2021 · Aug 5, 2020 · Open, Classified
  Computed Tomography X-Ray System, Model uCT 530, Rx, CE, GTIN: 06971576831012 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of
• Z-2704-2020 · Jun 20, 2020 · Open, Classified
  Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 - Product Usage: intended to produce cross-sectional images of the body using computer reconstr
• Z-2705-2020 · Jun 20, 2020 · Open, Classified
  Computed Tomography X-ray System; Model uCT 550; Rx; UDI: (01) GTIN: 06971576831036 - Product Usage: intended to produce cross-sectional images of the body using computer reconstr
• Z-2641-2020 · May 23, 2020 · Open, Classified
  Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 Intended use The uCT Computed Tomography X-ray System uCT 530/uCT 550 is a computed tomography X-ray system