Devices

Device Recall Acuson Antares Utrasound imaging device

Model / Serial
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.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
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.
Product Description
Acuson Antares Ultrasound Imaging System with software versions 4.0 and 5.0.
Manufacturer
Siemens Medical Solutions USA, Inc.
1 Event
- Recall of Device Recall Acuson Antares Utrasound imaging device

Manufacturer

Siemens Medical Solutions USA, Inc.

Manufacturer Address
Siemens Medical Solutions USA, Inc., 1230 Shorebird Way, P.O. Box 7393, Mountain View CA 94043
Manufacturer Parent Company (2017)
Siemens Ag
Source
USFDA

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