Class 3 Device Recall Acuson Cypress Echocardiography System

• Date Initiated by Firm: February 02, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on August 19, 2004
• Recall Number: Z-0744-04
• Recall Event ID: 28393
• 510(K)Number: K021497
• Product Classification: System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
• Product: Acuson Cypress Echocardiography System
• Code Information: Catalog number 8264604; Serial numbers 73480 through 73535, 71165, 71561, 72532, 73125, and 73292.
• FEI Number: 3002626007
• Recalling Firm/ Manufacturer: Siemans Medial Solutions USA, Inc; 5168 Campus Dr; Plymouth Meeting PA 19462-1123
• For Additional Information Contact: Linda Nash; 800-367-3569
• Manufacturer Reason for Recall: software problem - mode does not appear on screen
• FDA Determined Cause: Other
• Action: The recalling firm telephoned their direct accounts to inform them of the problem and the need to modify the software. The call were made from 2/2-16/04. The modification kits were sent to consignees via express delivery.
• Quantity in Commerce: 46 units
• Distribution: The product was shipped to physicians and medical facilities in AZ, CA, CT, FL, IA, IL, NE, NV, NY, OH, TX, and WA. The product was also shipped to Australia, Brazil, Canada, Denmark, Germany, Italy, Japan, New Zealand, South Korea, and Sweden.
• 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 = IYN