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FLUOROspeed 566-23000-03Recalls & reported problems

Shimadzu Corporation · Class 2

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.

1 other recall cover devices cleared under the same FDA submission (K191877); 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. Sep 6, 2024Open, Classified

    X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lead to the possibility of delay or cancellation of the examination.

    Z-0317-2025 · Root cause: Software change control · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K191877. One submission often covers many models, so check the product and lot details in each record.

  • Z-0867-2022 · Jan 10, 2022 · Open, Classified
    MODEL: X-RAY R/F SYSTEM FLUOROspeed X1

Other System, X-Ray, Fluoroscopic, Image-Intensified devices

All System, X-Ray, Fluoroscopic, Image-Intensified devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.