Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report 9/17/2008
Class:lll
PRODUCT
a) ACUSON Antares 5.0 ultrasound system at SW revision 200.0.054 or 200.0.059A,
with one of the following options installed: 3-Scape Imaging, Factory, PN 5937011
or 3-Scape Real Time Imaging, UPG ACU, PN 10033688. Material number
10032746, 10037592, 10032746, 10037591 or 10038202; Recall # Z-1766-2008;
b) Sonoline Antares 5.0 ultrasound system at SW revision 200.0.054 or 200.0.059A,
with one of the following options installed: 3-Scape Imaging, Factory, PN 5937011
or 3-Scape Imaging, Field Upgrade, PN 07472520. Material number 5936518,
8653771 or 10037593; Recall # Z-1767-2008
REASON
Software issues may result in distorted images and inaccurate measurements, which could lead to a misdiagnosis.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Mountain View, CA, by site visits on March 21, 2008. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
539 units
DISTRIBUTION
Nationwide and Internationally
