Events

Device Recall MEVATRON M 6730/6740 (MEX) 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
    76459
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1435-2017
  • 사례 시작날짜
    2017-01-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-10-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153262
  • 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
    Accelerator, linear, medical - Product Code IYE
  • 원인
    Siemens became aware of a defective weld seam at overhead suspensions. due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. this can lead to a severe injury to a patient or any other person.
  • 조치
    Siemens sent a Customer Safety Advisory Notice (CSAN) dated February 7, 2017, to affected customers to inform them of a planned hardware update regarding the mechanics of the overhead suspension of their Digital Linear Accelerator. The notice also explained the actions Siemens is taking to perform the necessary fix at the affected sites. Customers were advised to notify anyone at their organization that should be aware of this information. Also, the safety notice should be forwarded to the new owner and Siemens also requested they be informed of the identity of the device's new owner where possible. Customers with questions were instructed to call 1-800-888-7436. For questions regarding this recall call 610-448-6478.

Device

Device Recall MEVATRON M 6730/6740 (MEX)
  • 모델명 / 제조번호(시리얼번호)
    Device Model Number 8319758 Serial numbers: 3009 2958 2863 2972 2646 3079 2516 2962 3055 1452 2702 2125 3066 2689 2228 2564 2507 1904 3075 2375 3013 3068 2596 3025 3049 2965 2045 3084 2855 2906 2292 2384 2067 2818 3089
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    MEVATRON M 7400/7440(MEX) Accelerator, Linear, Medical || The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • 제조사 주소
    Siemens Medical Solutions USA, Inc, 40 Liberty Blvd, Malvern PA 19355-1418
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA