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U.S. Department of Health and Human Services

Class 2 Device Recall Alphenix, INFX8000C/B, INFX8000C/S, V9.2

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  Class 2 Device Recall Alphenix, INFX8000C/B, INFX8000C/S, V9.2 see related information
Date Initiated by Firm June 22, 2023
Date Posted August 11, 2023
Recall Status1 Open3, Classified
Recall Number Z-2392-2023
Recall Event ID 92664
510(K)Number K210900  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product INFX-8000C XGCP-930AA TABLE SIDE CONSOLE,
INFX-8000C XGCP-930BA TABLE SIDE CONSOLE
Code Information UDI-DI: 04987670100192. INFX-8000C, Serial Numbers: BHA1992001, BHB2132003, SWC2242002, AFB1832003, SUC2262008, SUC2292010, BFB1972004, SUB2172002, SWC2262003
Recalling Firm/
Manufacturer		 Canon Medical System, USA, INC.
2441 Michelle Dr
Tustin CA 92780-7047
For Additional Information Contact
714-730-5000
Manufacturer Reason
for Recall		 The C-arm, used to set the position and angle of the x-ray exposure field, may not function due to the tableside console PWB, which needs replacement. There may be a delay in the procedure, but procedures can continue using the operators console, the switches on the back of the column, switches on the side of the flat panel detector, and the emergency stop will continue to function normally.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On 6/22/23 correction notices were emailed to customers who were advised of the following: If the table side control does not function then the procedure can continue using the operators console in the operator room, the switches on the back of the column and the switches on the side of the flat panel detector. The emergency stop should not be affected and will continue to function normally. Neither manual operation or auto positioning of the C-arm can be performed on the console during procedure, and the C-arm will not operate. A firm representative will contact you to schedule a time to replace the PWB on the console. Complete and return the customer reply form to RAffairs@us.medical.canon For questions, contact the InTouch team at intouchdispatch@us.medical.canon or your service representative at 800.521.1968
Quantity in Commerce 12
Distribution US Nationwide Distribution: NY, CO, IL, CA, MD, MN, WA
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 = Canon Medical Systems Corporation
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