Events

Device Recall Elekta SL Series/Precise Digital Accelerator. 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
    54559
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1159-2010
  • 사례 시작날짜
    2005-10-01
  • 사례 출판 날짜
    2010-03-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-03-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88716
  • 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
    Accelerator, linear, medical - Product Code IYE
  • 원인
    Customer reported larger than expected variations in wedge factory with gantry rotation.
  • 조치
    Important Notice A280 "Wedge Matching Procedure" (dated 11/18/05) was sent to all effected customers. The Important Notice described the issue, warnings and cautions and corrective instructions/Maintenance to take to eliminate occurrence. Direct questions to your local Elekta Limited representative.

Device

Device Recall Elekta SL Series/Precise Digital Accelerator.
  • 모델명 / 제조번호(시리얼번호)
    Model SL15, Serial Nos. 105102, 105333, 105481, 105279, 1054424, 105325, 105364, 105387, 105291, 105280, 105261, 105297, 105355, 105386, 105342, 105367; Model SL18, Serial Nos. 105213, 105392, 105395, 105326, 105203, 105369, 105284, 105153, 105166, 105324, 105265, 105320, 105177, 105305, 105122, 105199, 105359, 105366, 105126, 105363, 105178, 105233; Model SL25, Serial Nos. 105013, 105204, 105245, 105373, 105376, 105275, 105277, 105127, 105196, 105393, 105186, 105217, 105210, 105117, 105137, 105215105194, 105195, 105228, 105236, 105235, 105104, 105240, 105368; Model PRECISE ACC, Serial Nos. 105992, 105894, 105563, 105806, 105902, 105627, 105706, 105785, 105821, 105871, 105648, 105655, 105882, 105960, 105754, 105886, 105606, 105585, 105731, 105989, 105727, 105782, 151075, 151077, 151098, 105841, 151099, 105630, 151014, 105895, 105816, 105864, 105846, 1055559, 105657, 105853, 105854, 105829, 151016, 105660, 105844, 105890, 105621, 105587, 151035, 105580, 105809, 105644, 105593, 105705, 105699, 105803, 105723, 105647, 105898, 105369, 105949, 105868, 105998, 105637, 105837, 105636, 105716, 105717, 151029, 105759, 105770, 105772, 105776, 105925, 105568, 105650, 105591, 105929, 105584, 105624, 105941, 105666, 108573, 105926, 105646, 105676, 105260, 105773, 105936, 105872, 105678, 151159, 151030, 105910, 105969, 151015, 105812, 105796, 105950, 105881, 105859, 105728, 105561, 105590, 105612, 105567, 105744, 105566, 105879, 105828, 105856, 105918, 105555, 105610, 105883, 105914, 105990, 105586, 151154, 105649, 105565, 105564; Model SYNERGY PLAT, Serial Nos. 151033, 151216, 151173, 151053, 105826, 151200, 151201, 151116, 151025, 151160, 105982, 151256, 151076, 151110, 151008, 151093, 151229, 105932, 151143, 151038, 151059, 151260, 151130, 151024, 151214, 151167, 151051, 151176, 151080, 151104, 151259, 151238, 151084, 105984, 151155, 151156, 151157, 151074, 151266, 151134, 151141, 151055, 151073, 151178, 151168, 151151; Model SL20, Serial Nos. 105285, 105093, 105321, 105358, 105286, 105295, 105249, 105274, 105288, 105381, 105403, 105323, 105319, 105312, 105316, 105257, 105267, 105207, 105057, 105351, 105327, 105273, 105185, 105339, 105300, 105187, 105382, 105154; Model SL75/5, Serial Nos. 103137, 103172, 103174, 103092, 103091, 103130, 103131, 103124, 103394, 103099, 103159, 103081, 103384, 103026, 103053, 103050, 103110, 103001, 103177, 103161, 103030, 103084, 103064, 103055, 103154, 103399, 103346, 103375, 103027, 103386; Model SL1+, Serial Nos. 105447, 105465, 105518, 105528, 105514, 105478, 105466, 105519, 105498, 105453, 105492, 105467, 105445, 105452; Model SL1, Serial Nos. 105475, 105521, 105549, 105494, 105437, 105503, 105530, 105544, 105488, 105515, 105482, 105532; Model SL75/20, Serial Nos. 273, 266, 269, 274
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    United States, Canada and Mexico.
  • 제품 설명
    Elekta SL Series/Precise Digital Accelerator. || The product is used with radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
  • 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