Date Initiated by Firm |
June 29, 2010 |
Date Posted |
November 01, 2010 |
Recall Status1 |
Terminated 3 on December 22, 2010 |
Recall Number |
Z-0168-2011 |
Recall Event ID |
56794 |
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 CA 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 |
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 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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