Events

Mevatron KD2 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
    46157
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0681-2008
  • 사례 시작날짜
    2007-08-07
  • 사례 출판 날짜
    2008-02-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-12-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66916
  • 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
    Linear Medical Accelerator - Product Code IYE
  • 원인
    Incorrect field size -- products manufactured prior to 1999 may experience jaw field size errors during interlock resulting in potential mistreatment if a light field check is not performed. this problem is present in machines with serial numbers less than 3094, as they do not contain redundant sensors for jaw position.
  • 조치
    The firm has sent consignees a Customer Safety Advisory Notice on August 7, 2007 informing them that a misplacement of the X and/or Y jaws can occur if interlock #51 Jaw Field Position is asserted and then cleared with the left-hand key rest. The firm recommends that if an interlock issue is encountered tha treatment of the patient be discontined until this issue is resolved.

Device

Mevatron KD2
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 1938, 1944, 1987, 2082, 2088, 2154, 2173, 2175, 2228, 2246, 2315, 2348, 1894, 1948, 1953, 2043, 2074, 2099, 2131, 2202, 2224, 2282, 2319, 2376, 2405, 2431, 2436, 2437, 2413, 2414, 1633, 1772, 1874, 1901, 1928, 1941, 1985, 2014, 2065, 2076, 2111, 2115, 2123, 2127, 2135, 2145, 2179, 2213, 2216, 2218, 2273, 2297, 2329, 2345, 2383
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution
  • 제품 설명
    Seimens Mevatron KD-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number: 9822685, Siemens Medical Solutions, Concord, CA 94520
  • 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