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U.S. Department of Health and Human Services

Class 3 Device Recall Volcano s5 Imaging System

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  Class 3 Device Recall Volcano s5 Imaging System see related information
Date Initiated by Firm April 02, 2007
Date Posted August 23, 2007
Recall Status1 Terminated 3 on June 03, 2008
Recall Number Z-1190-2007
Recall Event ID 38324
510(K)Number K051920  
Product Classification Ultrasound pulsed echo imaging system. - Product Code IYO
Product Volcano s5 Imaging system, Ultrasound pulsed echo imaging system. Product consists of the CPU, control console, monitor, printer, and patient interface module (PIM)
Code Information Device listing A863634, part number 804200-100. monitor part number that is being replaced: 90X0315A. All units shipped on or before November 2005.
Recalling Firm/
Manufacturer		 Volcano Corporation
2870 Kilgore Rd
Rancho Cordova CA 95670-6133
For Additional Information Contact
916-638-8008 Ext. 4503
Manufacturer Reason
for Recall		 During emissions testing, it was discovered that the product exceeds emissions limits for electromagnetic compatibility.
FDA Determined
Cause 2		 Other
Action The firm notified its customers by letter beginning April 2, 2007, and started replacing the monitor with appropriate replacement parts.
Quantity in Commerce 351 units worldwide
Distribution Product was distributed to health care facilities nationwide and to distributors in Europe (via subsidiary), Japan (via subsidiary), Latin America and Asia (third party distributors).
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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