Recalls / —

—#89308

Product

Acuson Antares Ultrasound Imaging System with software versions 4.0 and 5.0.

FDA product code

IYN — System, Imaging, Pulsed Doppler, Ultrasonic

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K023720, K033196, K050034, K063803

Affected 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.

Why it was recalled

Image captured from the device may be erroneous.

Root cause (FDA determination)

Software design

Action the firm took

Acuson Customer Safety Advisory notification letters were sent March 1, 2010 by certified mail.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc.

Address

1230 Shorebird Way P.O. Box 7393, Mountain View, California 94043

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2010-03-01

Posted by FDA

2011-03-30

Terminated

2012-06-18

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #89308. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.