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U.S. Department of Health and Human Services

Class 2 Device Recall Infinix INFX8000V, V6.40

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 Class 2 Device Recall Infinix INFX8000V, V6.40see related information
Date Initiated by FirmJanuary 31, 2022
Create DateSeptember 02, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1666-2022
Recall Event ID 90737
510(K)NumberK170909 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductINFX-8000V. For radiographic and fluoroscopic studies and intervention.
Code Information Model: Alphenix i with software version 8.0, 9.0 or 9.2 and the TFP 1200C FPD.
Recalling Firm/
Manufacturer		 Canon Medical System, USA, INC.
2441 Michelle Dr
Tustin CA 92780-7047
For Additional Information ContactGary Becker
800-421-1968
Manufacturer Reason
for Recall		The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.
FDA Determined
Cause 2		Software design
ActionCanon 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 intouchdispatch@us.medical.canon. For questions call 800-421-1968 or your Canon service representative at 800.521.1968.
Quantity in Commerce16 systems
DistributionUS Nationwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OWB
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