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U.S. Department of Health and Human Services

Class 2 Device Recall Acuson Antares Utrasound imaging device

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 Class 2 Device Recall Acuson Antares Utrasound imaging devicesee related information
Date Initiated by FirmMarch 01, 2010
Date PostedMarch 30, 2011
Recall Status1 Terminated 3 on June 18, 2012
Recall NumberZ-1853-2011
Recall Event ID 54844
510(K)NumberK023720 K033196 K050034 K063803 
Product Classification Utrasound imaging device - Product Code IYN
ProductAcuson Antares Ultrasound Imaging System with software versions 4.0 and 5.0.
Code Information ACUSON Antares: Model numbers: 10032747, 10037592, 10040728; SONOLINE Antares: Model numbers: 5936518, 08653771, 10037593; ACUSON Antares PE: Model Numbers: 10032746, 10037591, 10038202, 10040729. Serial Nos. beginning with 10 or 11 with software versions 4.0 and 5.0.
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc.
1230 Shorebird Way
P.O. Box 7393
Mountain View CA 94043
For Additional Information ContactKristen Dorrough
650-694-5993
Manufacturer Reason
for Recall
Image captured from the device may be erroneous.
FDA Determined
Cause 2
Software design
ActionAcuson Customer Safety Advisory notification letters were sent March 1, 2010 by certified mail.
Quantity in Commerce3539
DistributionWorldwide distribution to USA, Andorra, United Arab Emirates, Netherlands Antilles, Angola, Austria, Australia, Azerbaijan, Bosnia, Bangladesh, Belgium, Bahrain, Brunei Darussalam, Brazil, Belarus, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Germany, Denmark, Ecuador, Egypt, Spain, Finland, Faroe Islands, France, Great Britain, Georgia, Greece, Guatemala, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Iran, Italy, Jordan, Japan, South Korea, Kuwait, Lebanon, Sri Lanka, Lithuania, Latvia, Morocco, Moldova, Mexico, Nicaragua, Netherlands, Norway, New Zealand, Oman, Peru, Philippines, Pakistan, Poland, Portugal, Qatar, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovak Republic, Suriname, Thailand, Turkey, Trinidad and Tobago, Taiwan, Ukraine, UA, Uruguay, Venezuela, Vietnam, Yemen, and South Africa.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = IYN
510(K)s with Product Code = IYN
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