ACUSON Antares 5.0 Base System, model number 10042832. Distributed by Siemens Medical Solutions USA, Inc., Business Unit Ultrasound, Mountain View, CA. The ACUSON Antares is a general purpose Diagnostic Ultrasound system. Its function is to acquire primary or secondary harmonic ultrasound data and display it in: B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, Harmonic Imaging, or 3D/4D imaging on a FPD display. The Antares ultrasound imaging system is intended for the following applications: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures that provide information that is used for clinical diagnosis purposes.
FDA Recall Z-2118-2011 · Posted 2011-04-29
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Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Product CodeIYN
Date Initiated2009-05-15
Date Terminated2011-04-29
Product Quantity1 unit
Reason for Recall
Shock Hazard. The manufacturer failed to set the system power switch to "ON" during the line level leakage and high pot current draw testing.
Firm Action
Siemens Medical Solutions USA, Inc. sent a Customer Safety Advisory Notification letter out on May 15, 2009. Service engineers were to visit each customer to conduct necessary testing.
For questions regarding this recall call 650-694-5993.
Root Cause
Release of Material/Component prior to receiving test results
Distribution Pattern
Worldwide Distribution - USA including CA, IL, MD, NC, OH, and UT and the countries of Australia, China, Denmark, Spain, South Korea, Norway, Poland, Russia and Sweden.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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