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U.S. Department of Health and Human Services

Class 2 Device Recall Volcano brand Intravascular Ultrasound

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  Class 2 Device Recall Volcano brand Intravascular Ultrasound see related information
Date Initiated by Firm August 24, 2012
Date Posted September 10, 2012
Recall Status1 Terminated 3 on November 25, 2014
Recall Number Z-2345-2012
Recall Event ID 63102
510(K)Number K082229  K111706  
Product Classification System, imaging, pulsed echo, ultrasonic - Product Code IYO
Product Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02; Product is manufactured and distributed by Volcano Corporation, Rancho Cordova, CA.

Medical device for use in imaging of histology.
Code Information All units of these models. Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02
Recalling Firm/
Manufacturer		 Volcano Corporation
2870 Kilgore Rd
Rancho Cordova CA 95670-6133
For Additional Information Contact Neil O'Connor
800-228-4728
Manufacturer Reason
for Recall		 The display on the system has the potential to change. In house testing eventually identified the unique sequence of events that must occur in order for this issue to manifest itself.
FDA Determined
Cause 2		 Software design
Action Volcano Corporation sent an "IMPORTANT FIELD CORRECTIVE ACTION" letter dated August 24, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact your local Volcano sales representative or Volcano Customer Service for questions regarding this recall.
Quantity in Commerce 1020 units
Distribution Worldwide 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYO and Original Applicant = VOLCANO CORPORATION
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