Device Recall Acuson X300

  • Model / Serial
    Serial numbers
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries including: Albania, algeria, Argentina, Australia, Austria, Azerbaijan, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile,China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, India, Indonesia, Iran, Ireland, Italy, Japan, Kazakhstan, Kenya, Kosovo, Lativia, Lithuania, Luxembourg, New, Zealand, Nicaragua, Norway, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam.
  • Product Description
    Acuson X300 systems at software versions 1.00.00 to 1.0.10 and 2.0.00 to 2.0.02, model numbers 10037409, 10132987, and 10038837, manufactured by Siemens Medical Solutions ultrasound business unit, Mountain View, CA || Medical device is an ultrasound imaging system for general radiology, fetal, abdominal, intraoperative, pediatric, small parts, neonatal/adult cephalic, cardiac, transesophageal, pelvic, transcranial, ob/gyn, urology, vascular, musculoskeletal, superficial musculoskeletal and peripheral vascular applications. The system also provides for measurements of anatomical structures and for analysis packages 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

One device with a similar name

Learn more about the data here

  • Model / Serial
    Systems with software versions 3.0.00 and 3.0.02.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- Austria, Brazil, China, Columbia, Germany, Denmark, Egypt, Great Britain, Honduras, Ireland, India, Italy Japan, South Korea, Mexico, Malaysia, Peru, Poland, Portugal, Romania, Russia, Sweden, Singapore, Thailand, Turkey, Taiwan, United States, Uruguay, Venezuela, and South Africa.
  • Product Description
    Siemens ACUSON X300 Systems with software versions 3.0.00 and 3.0.02, model numbers 10348531, 10348532 and 10348533, manufactured by Siemens Medical Solutions, Mountain View, CA. || Intended for General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
  • Manufacturer