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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 Recall
Volcano s5 Imaging System
see related information
Date Posted August 23, 2007
Recall Status1 Terminated on June 03, 2008
Recall Number Z-1190-2007
Recall Event ID 38324
Premarket Notification
510(K) Number
Product Classification System, Imaging, Pulsed Echo, Ultrasonic - 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/
Volcano Corporation
2870 Kilgore Rd
Rancho Cordova, California 95670-6133
Manufacturer Reason
for Recall
During emissions testing, it was discovered that the product exceeds emissions limits for electromagnetic compatibility.
FDA Determined
Cause 2
DESIGN: Device Design
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 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