Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Infinix INFX8000V, V6.40

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Infinix INFX8000V, V6.40 see related information
Date Initiated by Firm January 31, 2022
Create Date September 02, 2022
Recall Status1 Open3, Classified
Recall Number Z-1666-2022
Recall Event ID 90737
510(K)Number K170909  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product INFX-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 Contact Gary 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
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 intouchdispatch@us.medical.canon. For questions call 800-421-1968 or your Canon service representative at 800.521.1968.
Quantity in Commerce 16 systems
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = OWB and Original Applicant = Toshiba Medical Systems Coroporation
-
-