Events

Device Recall ACUSON SC2000 Ultrasound System 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
    70362
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1056-2015
  • 사례 시작날짜
    2015-01-12
  • 사례 출판 날짜
    2015-02-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-11-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133313
  • 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
    System, imaging, pulsed doppler, ultrasonic - Product Code IYN
  • 원인
    The bolt holding the control panel of the acuson sc2000 in a fixed position may fail and the control panel cannot be locked into position.
  • 조치
    Siemens Medical sent an Customer Safety Advisory Notification to all affected customers on January 12, 2015 , via Certified mail, return receipt requested.The letter identified the product the problem and the action needed to be taken by the customer. At this time there is not mitigation to avoid risk associated with this issue. Local Customer Service Engineers will be contacting each site to replace the console. Until the necessary repairs have been completed, please share the information with all uses of the device. If you have any questions, please contact your local service support person for information regarding timelines and status. Until the necessary repairs have been completed on your system, please share this information with all personnel within your organization who need to be aware of this issue. As always, patient safety issues are a very high priority. To date, no patient injury has been reported. This problem was discovered as part of our ongoing quality process. We sincerely regret any inconvenience this condition may cause in your daily operations. For further questions please call (650) 694-5398.

Device

Device Recall ACUSON SC2000 Ultrasound System
  • 모델명 / 제조번호(시리얼번호)
    Model number 10433816. serial numbers 401100 to 401400.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA and the countries of Australia, Austria, Belarus, Canada, Ecuador, Finland, France, Georgia, Germany, India, Iraq, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Nigeria, P.R. China, Philippines, Portugal, Republic Korea, Russian Fed., Saudi Arabia, Serbia, South Africa, Spain, Suriname, Sweden, Taiwan, Turkey, U.A.E. and United Kingdom.
  • 제품 설명
    ACUSON SC2000 Ultrasound System, Model 10433816, component 10040596 - UILK2. || The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
  • Manufacturer
    Siemens Medical Solutions USA, Inc.

Manufacturer

Siemens Medical Solutions USA, Inc.
  • 제조사 주소
    Siemens Medical Solutions USA, Inc., 685 E Middlefield Rd, Mountain View CA 94043-4045
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA