Acuson Antares Ultrasound Imaging System with software versions 4.0 and 5.0.
This recall has been terminated (originally issued March 30, 2011).
- Recall Initiated
- March 1, 2010
- Posted
- March 30, 2011
- Terminated
- June 18, 2012
- Recall Number
- Z-1853-2011
- Quantity
- 3539
- Firm Location
- Mountain View, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Image captured from the device may be erroneous.
Distribution
Worldwide 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.
Lot / Code Info
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.
Root Cause
Software design
Action Taken
Acuson Customer Safety Advisory notification letters were sent March 1, 2010 by certified mail.