FDR Visionary SuiteRecalls & reported problems across all models
Shimadzu Corporation · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name at least one FDR Visionary Suite model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 4
We found 3 models of FDR Visionary Suite by Shimadzu Corporation in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.
4 FDA recall records name at least one of these models by its device identifier, 3 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
FDR Visionary Suite 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.
- Jan 9, 2026Open, 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 · names 3 of these models · Recall details · FDA record ↗
- Sep 15, 2025Open, 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 · names 3 of these models · Recall details · FDA record ↗
- Apr 11, 2024Open, 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 ↗
- Jun 15, 2017Terminated
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 ↗
FDR Visionary Suite models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- FDR Visionary Suite 566-16130-23System, X-Ray, Stationary4 recalls0 reports
- FDR Visionary Suite 566-16130-31System, X-Ray, Stationary2 recalls0 reports
- FDR Visionary Suite 566-16130-33System, X-Ray, Stationary2 recalls0 reports
Other Shimadzu Corporation products
All Shimadzu Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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