Events

Retiro De Equipo (Recall) de ACUSON and SONOLINE Antares and Antares PE ultrasound systems

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Siemens Medical Solutions USA, Inc., Mountain View, CA.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    56840
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1836-2011
  • Fecha de inicio del evento
    2010-08-17
  • Fecha de publicación del evento
    2011-03-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94614
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System, imaging, pulsed doppler ultrasonic - Product Code IYN
  • Causa
    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.
  • Acción
    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.

Device

ACUSON and SONOLINE Antares and Antares PE ultrasound systems
  • Modelo / Serial
    All units of these models.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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)
  • Descripción del producto
    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.
  • Manufacturer
    Siemens Medical Solutions USA, Inc., Mountain View, CA

Manufacturer

Siemens Medical Solutions USA, Inc., Mountain View, CA
  • Dirección del fabricante
    Siemens Medical Solutions USA, Inc., Mountain View, CA, 1230 Shorebird Way, P.O. Box 7393, Mountain View CA 94043
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA