Device Recall ACUSON Sequoia System

  • Model / Serial
    Serial numbers: 69275, 69301, 69313, 69335, 69347, 69353, 69366, 69391, 69403, and 69411.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    ACUSON Sequoia 12.X C512/512 SS Base System, model number 10042700. Distributed by Siemens Medical Solutions USA, Inc., Business Unit Ultrasound, Mountain View, CA. || The ACUSON Sequoia 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 imaging on a FPD Display. The ACUSON Sequoia is intended for the following applications: Abdominal, General Imaging and Cardiolgoy for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breat, testes, thyroid and penis), Neonatal/Adult Cephalic, Cardiac (adult, pediatric and neonatal), Transesophageal, Transrectal, Transvaginal, Peripheral Vessels and Musculo-sceletal (superficial and conventional) applications. The system also provides for the measurement of anatomical structures that provide information that is used for clinical diagnosis purposes.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Siemens Medical Solutions USA, Inc., 1230 Shorebird Way, P.O. Box 7393, Mountain View CA 94043
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

  • Model / Serial
    Serial numbers: 66214, 69268, 69302, and 69356.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    ACUSON Sequoia C512/512SS Adv PE 10.0 System, model number 10041127. Distributed by Siemens Medical Solutions USA, Inc., Business Unit Ultrasound, Mountain View, CA. || The ACUSON Sequoia 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 imaging on a FPD Display. The ACUSON Sequoia is intended for the following applications: Abdominal, General Imaging and Cardiolgoy for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breat, testes, thyroid and penis), Neonatal/Adult Cephalic, Cardiac (adult, pediatric and neonatal), Transesophageal, Transrectal, Transvaginal, Peripheral Vessels and Musculo-sceletal (superficial and conventional) applications. The system also provides for the measurement of anatomical structures that provide information that is used for clinical diagnosis purposes.
  • Manufacturer
  • Model / Serial
    Serial numbers: 69243, 69250, 69299, 69310, 69315, 69318, 69320, 69331, 69339, 69342, 69345, 69352, 69358, 69360, and  69406.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    ACUSON Sequoia 12.X GI Base System, model number 10042701. Distributed by Siemens Medical Solutions USA, Inc., Business Unit Ultrasound, Mountain View, CA. || The ACUSON Sequoia 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 imaging on a FPD Display. The ACUSON Sequoia is intended for the following applications: Abdominal, General Imaging and Cardiolgoy for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breat, testes, thyroid and penis), Neonatal/Adult Cephalic, Cardiac (adult, pediatric and neonatal), Transesophageal, Transrectal, Transvaginal, Peripheral Vessels and Musculo-sceletal (superficial and conventional) applications. The system also provides for the measurement of anatomical structures that provide information that is used for clinical diagnosis purposes.
  • Manufacturer