CH-200M 503-79470-06Recalls & reported problems
Shimadzu Corporation · Class 1
All models of CH-200M (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 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, 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 16, 2026.
Recalls naming this device
- Oct 16, 2025Open, Classified
Due to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly that could potentially result assembly coming off the rotating shaft.
Z-0499-2026 · Root cause: Device Design · Recall details · FDA record ↗
Other Tube Mount, X-Ray, Diagnostic devices
- CH-200M 563-58100-47Shimadzu Corporation · Tube Mount, X-Ray, Diagnostic1 recall0 reports
- CH-200 503-58100-34Shimadzu Corporation · Tube Mount, X-Ray, Diagnostic1 recall0 reports
- CH-200 503-58100-26Shimadzu Corporation · Tube Mount, X-Ray, Diagnostic1 recall0 reports
- SEDECAL CS NOVA FASedecal · Tube Mount, X-Ray, Diagnostic1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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