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U.S. Department of Health and Human Services

Class 2 Device Recall INFX8000 series

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  Class 2 Device Recall INFX8000 series see related information
Date Initiated by Firm February 05, 2021
Create Date March 09, 2021
Recall Status1 Open3, Classified
Recall Number Z-1175-2021
Recall Event ID 87419
510(K)Number K152697  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product System INFX-8000C
Code Information Model: CAS-880A, CAS-830B
Recalling Firm/
Manufacturer		 Canon Medical System, USA, INC.
2441 Michelle Dr
Tustin CA 92780-7047
For Additional Information Contact Director Regulatory Affairs
800-521-1968
Manufacturer Reason
for Recall		 The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.
FDA Determined
Cause 2		 Software design
Action A customer notification letter was sent to affected customers, which includes instructions to (1) manually operate the diaphragm blades of the collimator to adjust the X-ray irradiation field to the appropriate irradiation field position, (2) when adjusting the diaphragm blades, you can find this problem by checking the position of the diaphragm blades with respect to the image receiving surface displayed on the screen, (3) contact their Canon Service representative if they find any abnormalities regarding this issue in the operation of the Infinix System and if they have any questions. And includes a statement that Canon Medical Solutions USA will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Service, the details of which will be included in a subsequent communication to you or Canon field engineer site visit.
Quantity in Commerce 272 in total
Distribution Nationwide
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 CORPORATION
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