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U.S. Department of Health and Human Services

Class 2 Device Recall Volcano s5/s5i imaging system software version 3.2

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 Class 2 Recall
Volcano s5/s5i imaging system software version 3.2
see related information
Date Posted November 01, 2010
Recall Status1 Terminated on December 22, 2010
Recall Number Z-0168-2011
Recall Event ID 56794
Premarket Notification
510(K) Number
K082229 
Product Classification System, Imaging, Pulsed Echo, Ultrasonic - Product Code IYO
Product Volcano s5/s5i imaging system Family Software version 3.2, Part Numbers 435-0602.01 to 05, including ChromaFlo and Virtual Histology, manufactured by Volcano Corporation of Rancho Cordova, CA.
Code Information Software version 3.2, Part Numbers 435-0602.01 to 05,
Recalling Firm/
Manufacturer
Volcano Corporation
2870 Kilgore Rd
Rancho Cordova, California 95670-6133
For Additional Information Contact Volcano Customer Service
800-228-4728
Manufacturer Reason
for Recall
Software defect results in improper image brightness, which may result in introduction of artifacts, which may cause misclassification of results and affect classification of tissue types. This may result in misdiagnosis and inappropriate treatment.
FDA Determined
Cause 2
DESIGN: Software Design
Action Volcano issued a Voluntary Recall of Volcano s5 Family Software version 3.2 letter dated June 30, 2010, identifying the software defect and actions to be taken by Volcano. Field Service Engineers will visit each site and reinstall the previous software version, which will resolve the issue. Customers can contact Volcano at 916 281-2790.
Quantity in Commerce 79 software kits
Distribution Worldwide Distribution: USA, and the countries of France, Germany, Japan, and the UK.
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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