FDR Visionary Suite 566-16130-23Recalls & reported problems

Summary

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

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

1 other recall cover devices cleared under the same FDA submission (K152294); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jan 9, 2026Class IIOpen, Classified

   It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit even if the power of the device is cut off. As a result, it cannot be denied that the circuit in question overheats and damages the surrounding parts. It may also cause smoke.

   Z-1299-2026 · Root cause: Process control · Recall details · FDA record ↗

2. Sep 15, 2025Class IIOpen, Classified

   It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front while lifting.

   Z-0044-2026 · Root cause: Device Design · Recall details · FDA record ↗

3. Apr 11, 2024Class IIOpen, Classified

   Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury

   Z-1898-2024 · Root cause: Component design/selection · Recall details · FDA record ↗

4. Jun 15, 2017Class IITerminated

   A potential issue in the X-ray tube ceiling unit CH-200 which constitutes the Digital Radiography System FDR Visionary Suite. The X-ray tube assembly in these devices is mounted to a tube mounting flange, which is part of the tube holding shaft. where cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.

   Z-0232-2018 · Root cause: Device Design · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152294. One submission often covers many models, so check the product and lot details in each record.

• Z-2655-2017 · May 23, 2017 · Terminated
  SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ray system for taking general radiographic and tomographic images of the whole body. The device is intended