Events

LeVeen Coaccess Needle Electrode 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Boston Scientific Corporation 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
    63336
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0080-2013
  • 사례 시작날짜
    2012-09-17
  • 사례 출판 날짜
    2012-10-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-07-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113532
  • 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
    Electrode, electrosurgical - Product Code JOS
  • 원인
    Leveen standard and leveen coaccess needle electrode system, directions for use(dfu) in portuguese, are incorrect. all other languages in the dfu are correct. consignees in brazil, portugal,and hong-kong are being notified.
  • 조치
    Boston Scientific sent notifications, dated September 17, 2012, to each account in Brazil, Portugal and Hong Kong affected by the recall. The affected accounts were provided the corrected pages of the Portuguese DFU as part of the communication to ensure that those users that rely on the Portuguese DFU have the correct information.

Device

LeVeen Coaccess Needle Electrode
  • 모델명 / 제조번호(시리얼번호)
    Material Catalog Number: MOO1262230 with lot numbers: 12293473, 12580337, 12639146, 12639181, 12642715,12647752,12651931,12653869, 12656587, 12663028, 12663626, 12667129, 12667787, 12741165, 12760565, 12799352, 12825090, 12849385, 12860811, 12895401, 12967872, 13002918, 13058416, 13096459, 13120668, 13166239, 13235239, 13309477, 13383272, 13399503, 13418415, 13463515, 13498936, 13545732, 13559348, 13665665, 13775008, 13805295, 13822358, 13872667, 13902427, 14076298, 14119776, 14131133, 14169885, 14206936, 14279112, and 14288333.  Material Catalog Number: MOO1262240 with lot numbers: 12341198, 12341781, 12348901, 12351784, 12533460,12533461,12533466,12533467, 12533468, 12600849, 12642716, 12651932, 12663627, 12663628, 12663629, 12667788, 12674036, 12674312, 12741166, 12771577, 12805833, 12805835, 12860812, 12876589, 12937149, 12953904, 12982469, 13020096, 13048075, 13075112, 13117330, 13169619, 13230606,13247208, 13254418, 13278009, 13299117, 13309317, 13352191, 13384075, 13415014,13476371, 13480767, 13545557, 13592399, 13605018, 13610851, 13677260, 13727387,13775007, 13798432, 13813580, 13822357,13837691, 13873878, 13875213, 13883193, 13883196, 13936544, 13940480, 13978762,14076299, 14096255, 14157926, 14169886,14169887, 14217955, and 14249334.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed in Brazil, Portugal and Hong Kong.
  • 제품 설명
    Leveen Coaccess Needle Electrode (3.5/15) and (4.0/15). || Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequency generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • 제조사 주소
    Boston Scientific Corporation, 100 Boston Scientific Way, Marlborough MA 01752-1234
  • 제조사 모회사 (2017)
    Boston Scientific
  • 제조사 의견
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA