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U.S. Department of Health and Human Services

Class 2 Device Recall Acuson Cypress Echocardiography System

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  Class 2 Device Recall Acuson Cypress Echocardiography System see related information
Date Initiated by Firm April 01, 2003
Date Posted July 02, 2003
Recall Status1 Terminated 3 on January 16, 2004
Recall Number Z-0975-03
Recall Event ID 26456
510(K)Number K021497  
Product Classification System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
Product Acuson Cypress Echocardiography System. Imaging System
Code Information Catalog # 8264604. Serial numbers 70000 through 72000.
Recalling Firm/
Manufacturer		 Siemans Medial Solutions USA, Inc
5168 Campus Drive
Plymouth Meeting PA 19462
For Additional Information Contact Beverly Magrane
800-367-3569
Manufacturer Reason
for Recall		 software problem - loss of data
FDA Determined
Cause 2		 Other
Action The recalling firm issued a letter dated 4/03 explaining the problem and the work around. A software upgarde is being provided free of charge to the customers.
Quantity in Commerce 1540 units
Distribution The device was shipped to hospitals and physicians nationwide. The device was also shipped to accounts in Argentina, Australia, Austria, Belgium, Boliva, Brazil, Canada, Chile, Columbia, Costa Rica, Cypress, Denmark, Egypt, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, South Korea, Kuwait, Luxembourg, Malaysia, Mexico, netherlands, Norway, Philippines, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Turkey, and United Kingdom.
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 and Original Applicant = ACUSON CORP.
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