INFX-8000V. For radiographic and fluoroscopic studies and intervention.
FDA Recall Z-1666-2022 · Posted None
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Recalling FirmCanon Medical System, USA, INC.
Recall StatusOpen, Classified
Product CodeOWB
Date Initiated2022-01-31
Product Quantity16 systems
Reason for Recall
The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.
Firm Action
Canon sent an Urgent Electronic Product Radiation Warning letter dated July 28, 2022 to customers. . Customer were informed that in the interim a temporary countermeasure will be performed until such time as the software becomes available. A representative of Canon Medical Systems USA will contact you to schedule a time to install the countermeasure and at a later date, the updated software to address the issue. For scheduling questions, please contact our InTouch team at [email protected]. For questions call 800-421-1968 or your Canon service representative at 800.521.1968.
Root Cause
Software design
Distribution Pattern
US Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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