Events

Device Recall PRIMEVIEW 3i System 2.0 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
    48432
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0097-2009
  • 사례 시작날짜
    2007-11-06
  • 사례 출판 날짜
    2008-10-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-12-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71403
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • 데이터 추가 비고
  • 원인
    Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail.
  • 조치
    Service calibration inspection/correction Update instructions TH038/07/S was issued on 11/06/2007 to all customers. The instructions identified the affected products, stated the reason for the update, and listed the steps to update the software. Customer notification was also issued. Software patch planned for release in June 2008.

Device

Device Recall PRIMEVIEW 3i System 2.0
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers associated with RTT2.0 and RTT2.1
  • 의료기기 분류등급
    Radiology Devices
  • 유통
    Worldwide Distribution
  • 제품 설명
    PRIMEVIEW 3i System 2.0 equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 8139847 || Medical charged-particle radiation therapy system.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • 제조사 주소
    Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord CA 94520-1200
  • Source
    USFDA