Terminated

ACUSON and SONOLINE Antares and Antares PE ultrasound systems at product versions 4.0 and 5.0 with cardiovascular options installed; ACUSON Antares 4.0 & 5.0: 10032747, 10037592, 10040728; ACUSON Antares PE 4.0 & 5.0: 10032746, 10037591, 10038202, 10040729; SONOLINE Antares 4.0 & 5.0: 05936518, 08653771, 10037593; Antares Cardio Options: 10036613, 10036588, 10036585, 10436250; Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Business Unit Ultrasound, Mountain View, CA The ACUSON Antare is a general purpose Diagnostic Ultrasound system. Its function is to acquire primary or secondary harmonic ultrasound echo 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-1836-2011 · Posted 2011-03-28

Recalling FirmSiemens Medical Solutions USA, Inc., Mountain View, CA

Recall StatusTerminated

Product CodeIYN

Date Initiated2010-08-17

Date Terminated2012-06-18

Reason for Recall

There is an error in the estimation of mean pressure gradient in the Cardiac measurement package. The currently implemented calculation will result in an underestimation of the mean pressure gradient (PGmean) when estimated from a trace of the Doppler waveform of the stenotic flow.

Firm Action

Siemens Medical Solutions USA, Inc., sent a Customer Safety Advisory Notification letter on August 17, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to pass the notice on to all those within their organization who need to aware of the issue until the corrective action was completed. For questions customers were to contact their local service support person. For questions regarding this recall call 650-694-5993.

Root Cause

Software change control

Distribution Pattern

Worldwide Distribution - USA (nationwide)and the countries of Antares distribution includes: United Arab Emirates-AE, Austria-AT, Australia-AU, Azerbaijan-AZ, Brazil-BR, Belarus-BY, Canada-CA, Switzerland-CH, Chile-CL, China-CN, Czech Republic-CZ, Germany-DE, Denmark-DK, Egypt-EG, Spain-ES, France-FR, Great Britain-GB, Guatemala-GT, Croatia-HR, Hungary-HU, Indonesia-ID, Ireland-IE, India-IN, Italy-IT, Jordan-JO, Japan-JP, South Korea-KR, Moldova-MD, Mexico-MX, Malaysia-MY, Netherlands NL, Norway-NO, New Zealand-NZ, Poland-PL, Portugal-PT, Romania-RO, Serbia-RS, Russian Federation-RU, Saudi Arabia-SA, Sweden-SE, Singapore-SG, Slovak Republic-SK, Suriname-SR, Turkey-TR, Taiwan-TW, Ukraine-UA, United States-US, Uruguay-UY, Uzbekistan-UZ, Venezuela-VE, Vietnam-VN, South Africa-ZA S2000 distribution includes: Austria-AT, Australia-AU, Brazil-BR, Canada-CA, Switzerland-CH, Chile-CL, China-CN, Czech Republic-CZ, Germany-DE, Denmark-DK, Spain-ES, Finland-FI, France-FR, Great Britain-GB, Hong Kong-HK, Indonesia-ID, India-IN, Italy-IT, Japan-JP, South Korea-KR, Kazakhstan-KZ, Lebanon-LB, Mexico-MX, Norway-NO, Philippines-PH, Poland-PL, Portugal-PT, Romania-RO, Russian Federation-RU, Sweden-SE, Slovak Republic-SK, Turkmenistan-TM, Turkey-TR, Taiwan-TW, United States-US X300 distribution includes: AE (United Arab Emirates) , AL (Albania) , AN (Netherlands Antilles), AO (Angola), AR (Argentina), AT (Austria), AU (Australia), AZ (Azerbaijan), BA (Bosnia-Herzegovina), BD (Bangladesh), BE (Belgium), BG (Bulgaria), BN (Brunei), BO (Bolivia), BR (Brazil), BY (Belarus), CA (Canada), CH (Switzerland), CL (Chile), CN (China), CO (Colombia), CV (Cape Verde), CZ (Czech Republic), DE (Germany), DK (Denmark), DZ (Algeria), EC (Ecuador), EG (Egypt), ES (Spain), ET (Ethiopia), FJ (Fiji), FR (France), GB (United Kingdom), GE (Georgia), GR (Greece), HK (Hong Kong), HN (Honduras), HR (Croatia), HU (Hungary), ID (Indonesia), IE (Ireland), IN (India), IR (Iran), IT (Italy), JO (Jordan), JP (Japan), KE (Kenya), KR (Korea, South), KW (Kuwait), KZ (Kazakhstan), LT (Lithuania), LV (Latvia), LY (Libya), MD (Moldova), ME (Montenegro), MK (Macedonia), MM (Myanmar), MU (Mauritius), MX (Mexico), MY (Malaysia), NG (Nigeria), NI (Nicaragua), NL (Netherlands), NO (Norway), NP (Nepal), NZ (New Zealand), PE (Per¿), PH (Philippines), PK (Pakistan), PL (Poland), PS (Palestine), PT (Portugal), QA (Qatar), RS (Serbia), RO (Romania), RU (Russia), RW (Rwanda), SA (Saudi Arabia), SC (Seychelles), SE (Sweden), SG (Singapore), SI (Slovenia), SK (Slovakia), SV (El Salvador), SY (Syria), TH (Thailand), TM (Turkmenistan), TN (Tunisia), TR (Turkey), TT (Trinidad/Tobago), TW (Taiwan, ROC), UA (Ukraine), US (United States of America), UY (Uruguay), UZ (Uzbekistan), VE (Venezuela), VN (Viet Nam), YE (Yemen), ZA and (South Africa)

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.