Terminated

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 05937011 or 3-Scape Imaging, Field Upgrade, PN 07472520. Material number 5936518, 8653771 or 10037593

FDA Recall Z-1767-2008 · Posted 2008-09-02

Recalling FirmSiemens Medical Solutions USA, Inc.

Recall StatusTerminated

Product CodeIYO

Date Initiated2008-03-21

Date Terminated2009-09-30

Product Quantity51 active units total

Reason for Recall

Software issue may result in distorted images and inaccurate measurements, which could lead to a misdiagnosis.

Firm Action

The firm initiated a field correction on 03/21/2008. Site visits to correct the problem and install the revised software version 200.0.063A are planned for all consignees. No other notification was made. The firm can be contacted at 650-694-5993.

Root Cause

Software design

Distribution Pattern

Product was distributed worldwide to 539 consignees, in the USA to MD, SC, AZ, FL, IL, WI, NJ, NC, CA, OH, VA TX, PA MO, NH, IA, NE, MN, NY, GA, MI, WA, HI, MA, SC, WV, VA, ND, IN, WY, UT, MS, TN, PR, SD, KY, OK, OR, and worldwide to Sweden, Saudi Arabia, Austria, New Zealand, Italy, Switzerland, Mexico, Germany, Australia, Canada, Great Britain, France, China, South Korea, Singapore, Denmark, Brazil, Poland, Norway, Faroe Islands, South Africa, Russian Federation, Romania, Trinidad and Tobago, Greece, India, Spain, Thailand, Ukraine, Nicaragua, Japan, India, Czech Republic, Egypt, Taiwan, Turkey, Malaysia, Qatar, Bosnia an dHerzogovina, Vietnam, Brunei Darussalam, Italy, Kuwait, Turkey, Portugal

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K063803ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEMSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007-01-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.