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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 Device Recall Volcano s5/s5i imaging system software version 3.2see related information
Date Initiated by FirmJune 29, 2010
Date PostedNovember 01, 2010
Recall Status1 Terminated 3 on December 22, 2010
Recall NumberZ-0168-2011
Recall Event ID 56794
510(K)NumberK082229 
Product Classification System, imaging, pulsed echo, ultrasonic - Product Code IYO
ProductVolcano 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,
FEI Number 2939520
Recalling Firm/
Manufacturer		 Volcano Corporation
2870 Kilgore Rd
Rancho Cordova CA 95670-6133
For Additional Information ContactVolcano 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		Software design
ActionVolcano 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 Commerce79 software kits
DistributionWorldwide Distribution: USA, and the countries of France, Germany, Japan, and the UK.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = IYO
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