Events

Device Recall ACUSON X300 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Medical Solutions USA, Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    53051
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2147-2011
  • 사례 시작날짜
    2009-07-24
  • 사례 출판 날짜
    2011-05-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-05-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84543
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Ultrasonic Pulsed Echo Imaging System - Product Code IYO
  • 원인
    Mistreatment risk-- when a user defined formula is used to calculate a value in a vascular exam, data is switched laterally when it is internally transferred and displayed on the summary report within the system.
  • 조치
    A field correction was initiated and a Customer Safety Advisory Notification was sent out on 7/29/09. The letter identified the affected product and stated that there was a potential for user defined calculations to be incorrect within the vascular package when using the listed software versions of the product. The letter also discussed the steps that customers could take to avoid the potential risk of the issue. A mandatory update software was developed and will be installed free of charge. Customers should have been contacted to schedule a time for the installation. Questions were to be directed to the local service support person.

Device

Device Recall ACUSON X300
  • 모델명 / 제조번호(시리얼번호)
    Systems with software versions 3.0.00 and 3.0.02.
  • 의료기기 분류등급
    Radiology Devices
  • 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
    Siemens Medical Solutions USA, Inc.

Manufacturer

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