Device Recall ACUSON X300

  • 모델명 / 제조번호(시리얼번호)
    Systems with software versions 3.0.00 and 3.0.02.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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
  • 1 Event

제조사

  • 제조사 주소
    Siemens Medical Solutions USA, Inc., 1230 Shorebird Way, P.O. Box 7393, Mountain View CA 94043
  • 제조사 모회사 (2017)
  • Source
    USFDA

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  • 모델명 / 제조번호(시리얼번호)
    Serial numbers
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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