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Terminated

Siemens, SONOLINE Antares Ultrasound System, 5.0 Systems with software version 200.0.054, P/N 05936518 and 10037593 , Siemens, Ultrasound Division, Mountain View, CA 94039

FDA Recall Z-0298-2008 · Posted 2008-01-09

Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Product CodeIYN
Date Initiated2007-07-10
Date Terminated2010-12-20
Product Quantity418 units (Z-0297-0298-2008)

Reason for Recall

Image error: A software problem results in on-screen indications (graphics) that lead the user to believe that the patient's right and left and the transducer orientation are oriented the same. This is not the case and the actual patient's right and left are reversed from the on-screen indicators.

Firm Action

The firm sent a recall letter, Urgent Medical Device Notification, to consignees on 07/10/2007, to be followed by a service visit by Siemens personnel for a mandatory software update to be installed. Short term the users were instructed to avoid increasing the SieClear compounding levels to an Advanced SieClear compounding setting after an L/R invert action with Biopsy guidelines on-screen.

Root Cause

Software design

Distribution Pattern

Worldwide: Product was distributed to medical facilities Nationwide including the states of OH, FL, IL, NY, CA, NH, TX, NJ, PA, MD, MO, GA, WA, WI, NE, WV, HI, MA, SC, MI, VA, AZ, UT, NH, RI, KY, SD, and IN, and internationally to Canada, Germany, Australia, Sweden, Saudi Arabia, Chile, South Korea, Mexico, France, UK, Taiwan, Singapore, Denmark, Brazil, New Zealand, Ireland, Belgium, Norway, Serbia, Vietnam, UK, Poland, China, Spain, South Africa, Austria, Croatia, Russia, Greece, Trinidad and Tobago, United Arab Emirates, India, Japan, Malaysia, Turkey, Thailand, Norway, Slovakia, Romania, Netherlands, Switzerland, Portugal, Italy, and Venezuela.

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.

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