Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 4/6/2011
Class ll:
PRODUCT
Acuson Antares Ultrasound Imaging System with software versions 4.0 and 5.0. Model numbers: 10032747, 10037592, 10040728; SONOLINE Antares: Model numbers: 5936518, 08653771, 10037593; ACUSON Antares PE: Model Numbers: 10032746, 10037591, 10038202, 10040729. Recall # Z-1853-2011
REASON
Image captured from the device may be erroneous.
RECALLING FIRM/MANUFACTURER
Serial Nos. beginning with 10 or 11 with software versions 4.0 and 5.0.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Mountain View, CA, by letters on March 1, 2010. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
3,539 units
DISTRIBUTION
Nationwide and Internationally
