Events

Device Recall Leksell GammaPlan 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
    57607
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1223-2011
  • 사례 시작날짜
    2005-10-01
  • 사례 출판 날짜
    2011-02-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-03-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96778
  • 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 IWB
  • 원인
    Investigation found that if a user accidentally selects the wrong image/tube position images can be displayed flipped.
  • 조치
    Product bulletin Leksell GammaPlan - "Leksell GammaPlan version 5.34" (dated October 2005) was sent to affected Customers as notification of the problem. Field Change Order FCO-DCO-05-0006 (dated November 22, 2005) and Technical Notes Leksell GammaPlan Leksell SurgiPlan Important Notice - "Potential issue using flipped angiographic images" (dated October 2005) was sent to Elekta Service Engineers as notification of the problem. The letters described the issue and the FCO asked the Service Engineers to confirm their receipt of the documentation. The Technical Notes also discussed image visualization requirements and listed recommendations.

Device

Device Recall Leksell GammaPlan
  • 모델명 / 제조번호(시리얼번호)
    SG33620363, US68537171, SG10821625, 3713G01281, SG03321319, SG33520213, US19502892, C160, SG0320704, SG44120295, 00000000000002, SG31630678, SG24820212, SG24820194, SG44221038, SG34620630, SG40920412, SG31020878, A4986A, SG11520160, SG44720158, SG41720310, SG43820213, 3416G09539, SG24820139, US19257221, SG33820630, 19476882, SG13320399H, SG40520126, SG50425261, SG41720317, US66320311, US19490144, SG21220130, US68154038, US19501776, SW ONLY, SG32520836, 3416G08464, SG21220113, SG44925638, SG04120289, SG51220179, SG2030679, US6824174, SG22920793, SG4820232, 3628G06513, 000000000000019, 00000000000004, US19310946, 3416G05185, US69131975, SG42520530, SG23320693, US68104248, SG23720396, SG24820231, SG14720637, SG43520759, US68513855, SG44820136, SG20220701, SG44120292, US19476874, US6863578, SG04020719, 3416G07810, SG43720660, SG44925635, US68538435, US19322820, SG33320960, US19319754, SG31620624, US10102906, SG44925637, SG43520477, US69172955, SG42720416, 3711C04231, US68154724, SG0620611, SG20220192, SG33620337, US19311023, SG35020182, US19239028, SG50425266, SG51920134, 000000000000011, SG44925633, SG24021335, 0304011939, A4986A, SG34220901, SG1220108, SG32120124, US69132547, SG43720550, US19476879, 6146A06124, SG41920535, 6412A00007, US68500234, US19322145, SG20220694, US68115508, SG41620718, SG10720353, 000000000000014, SG43520485, SG42820297, 000000000000015, SG41020267, US68104599, IE24488098, SG11421969, SG41720337, US6836799, US19344670, SG11720734, US68064889, SG20220679, 000000000000016, SG20220699, SG11421978, SG34220707, US19378673, SG34420200, SG20220143, SG50425271, US10025765, US90345020, US19345857, and SG13420315.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution
  • 제품 설명
    Leksell GammaPlan, Model 5.34. || Intended to be used for planning the dosimetry of treatments in stereotactic radiation therapy.
  • 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