Events

Device Recall Elekta Synergy 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Elekta, 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
    55098
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1441-2010
  • 사례 시작날짜
    2008-03-18
  • 사례 출판 날짜
    2010-04-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-12-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89889
  • 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
    Medical Linear Accelerator - Product Code IYE
  • 원인
    Installation of a touchguard to prevent injury to patients or staff by stopping machine movements in the case of accidental collision.
  • 조치
    An Important Notice A319 "Instructions for Use for Elekta Synergy kV Source Touchguard" dated 3/18/08 is in distribution to all affected customers. This letter identified the product and asked customers to file the Notice in the User Notice section of the appropriate User Manual. It also asked them to follow the instructions and the reason for the Notice. Questions should be directed to a local Elekta representative. Field Change Order (FCO) 514 259 "kV Source touchguard for systems with touchguard ready source covers" dated 10/17/08 was sent to all affected customers. FCO 514 260 "kV Source touchguard for systems with the original source covers" dated 10/17/08 was sent to all affected customers.

Device

Device Recall Elekta Synergy
  • 모델명 / 제조번호(시리얼번호)
    135003, 135013, 135015, 135020, 135022, 135023, 135024, 135025, 135028, 135035, 135036, 135037, 135038, 135042, 135046, 135047, 135055, 135056, 135058, 135061, 135062, 135063, 135065, 135068, 135071, 135072, 135073, 135076, 135079, 135085, 135087, 135090, 135093, 135096, 135100, 135101, 135103, 135105, 135110, 135111, 135113, 135118, 135119, 135121, 135122, 135124, 135125, 135126, 135144, 135150, 135151, 135157, 135158, 135163, 135164, 135167, 135168, 135170, 135172, 137173, 135175, 135177, 135181, 135182, 135184, 135189, 135191, 135190, 135192, 135195, 135196, 135199, 135200, 135206, 135207, 135208, 135209, 135210, 135211, 135215, 135216, 135224, 135225, 135226, 135227, 135230, 135233, 135237, 135241, 135247, 135251, 135256, 135258, 135262, 135271, 135272, 135274, 135277, 135278, 135282, 135285, 135296, 135298, 135303, 135306, 135313,135323, 135324, 151008, 151024, 151033, 151038, 151051, 151053, 151055, 151059, 151073, 151074, 151076, 151080, 151084, 151093, 151104, 151110, 151130, 151134, 151141, 151143, 151151, 151154, 151155, 151156, 151157, 151160, 151167, 151168, 151173, 151176, 151178, 151216, 151228, 151229, 151238, 151245, 151250, 151253, 151256, 151259, 151260, 151266, 151267, 151269, 151298, 151301, 151305, 151309, 151317, 151325, 151326, 151327, 151328, 151340, 151352, 151359, 151360, 151362, 151363, 151369, 151371, 151387, 151390, 151394, 151398, 151411, 151416, 151421, 151422, 151423, 151430, 151433, 151435, 151441, 151446, and 151479.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution -- Including Puerto Rico.
  • 제품 설명
    Elekta Synergy || Intended to be used for radiation therapy treatment of malignant neoplastic diseases.
  • Manufacturer
    Elekta, Inc.

Manufacturer

Elekta, Inc.
  • 제조사 주소
    Elekta, Inc., 4775 Peachtree Industrial Blvd, Bldg 300, #300, Norcross GA 30092-3011
  • 제조사 모회사 (2017)
    Elekta AB
  • Source
    USFDA