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U.S. Department of Health and Human Services

Class 2 Device Recall Ultrasound System

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  Class 2 Device Recall Ultrasound System see related information
Date Initiated by Firm September 30, 2009
Date Posted January 12, 2011
Recall Status1 Terminated 3 on June 18, 2012
Recall Number Z-0896-2011
Recall Event ID 54718
510(K)Number K052021  
Product Classification Transducer, ultrasonic, diagnostic - Product Code ITX
Product Acuson Antares Ultrasound System
Diagnostic Ultrasound system
Code Information Model Numbers begins with 1003, 1004, 059 and 086 with product version 5.0, and softeare version 200.0.079
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc.
1230 Shorebird Way
P.O. Box 7393
Mountain View CA 94043
For Additional Information Contact
650-694-5993
Manufacturer Reason
for Recall		 Software safety guard measures on the device malfunctioned to prevent the temperature from going over its limits when the device is used.
FDA Determined
Cause 2		 Software design
Action Field notification in the form of a Customer Safety Advisory Notice was initiated on 09/30/2009 by the firm, and the notice was mailed to all affected customers Siemens sent a CUSTOMER SAFETY ADVISORY NOTIFICATION letter on September 30, 2009. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to disconnect and reconnect the V5Ms transducer between uses until their local Customer Service Engineer installs the software update to their system. For any questions customers were to contact their local service support person. For questions regarding this recall call 650-694-5398.
Quantity in Commerce 452
Distribution Worldwide Distribution - United States (nationwide) and the countries of Australia, Austria, Azerbaijan, Brazil, Belarus, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Guatemala, Croatia, India, Indonesia, Italy, Jordan, Japan, Latvia, Malaysia, Mexico, Moldova, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.
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 = ITX and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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