Events

Device Recall Leksell SurgiPlan 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
    55144
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1428-2010
  • 사례 시작날짜
    2005-05-23
  • 사례 출판 날짜
    2010-04-22
  • 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=90064
  • 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
    Radionuclide radiation therapy system - Product Code HAW
  • 원인
    Images from a different patient can be imported without a warning for the user.
  • 조치
    Phase I - A technical note for LGP and SPS describing the risk for importing wrong image files and including recommendations on how to reduce this risk has been written and distributed to users of both Leksell GammaPlan and Leksell SurgiPlan on May 23, 2005 via FCO DOC 05-0001. Phase 2 - A maintenance release was created of the Scanner Interface (SIF) to correct the problem. This was distributed to Leksell SurgiPlan users on November 30, 2005 via FCO0000153-1. Additional questions are directed to the firm to Product Manager lrobert.aslund AT elekta.com, or After Sales gustaf.piehl AT elekta.com..

Device

Device Recall Leksell SurgiPlan
  • 모델명 / 제조번호(시리얼번호)
    US68104248, SG50425261, US68154313, US66320311, 3415G15729, 3416G05185, SW ONLY, 3416G07810, 3416G08464, US19311023, SG5121735, SG44720158, 000000000000010, SG33221023, 000000000000015, SG41020267, US19477688, SG14720637, SG31020878, SG21220437, IE24488098, SG11720734, US6836799, SG20220679, US68064889, US19344670, SG41720337, SG44820136, US6863578, US68247174, SG20220701, 000000000000011, 6458A30012, HP715/80, 000000000000019, 3628G06513, SG5020708, SG31120383, LGP-SG13420315, 000000000000014, 00000000000004, 3711C04231, US68154724, C160, SG33820630, 00000000000002, 000000000000013, 6146A06124, SG41920535, 6513A30173, 0304011939, A4986A, SG20220694, 000000000000016, SG20220699, 6601A30228, US19476876
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide, Canada and Mexico.
  • 제품 설명
    Leksell SurgiPlan
  • 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