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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 Recall
Volcano brand Intravascular Ultrasound
see related information
Date Posted September 10, 2012
Recall Status1 Terminated on November 25, 2014
Recall Number Z-2345-2012
Recall Event ID 63102
Premarket Notification
510(K) Numbers
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.
Recalling Firm/
Manufacturer
Volcano Corporation
2870 Kilgore Rd
Rancho Cordova, California 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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IYO and Original Applicant = VOLCANO CORPORATION
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