Class 3 Device Recall Volcano s5 Imaging System

• Date Initiated by Firm: April 02, 2007
• Date Posted: August 23, 2007
• Recall Status: Terminated 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: 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