Events

Device Recall LIGHTWAVE SUCTION ABLATOR 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Linvatec Corp. dba ConMed Linvatec 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
    52811
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2051-2009
  • 사례 시작날짜
    2009-07-31
  • 사례 출판 날짜
    2009-09-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-02-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84052
  • 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
    Electrosurgical Cutting and Coagulation Device and Accessories - Product Code GEI
  • 원인
    Conmed linvatec has determined there is a possibility that the device may not shut off if the ablate button is released, which may result in users/patients suffering burns.
  • 조치
    ConMed Linvatec is notifying their direct consignees by an Urgent Medical Device Recall letter, requesting that customers check their inventory for the affected products; complete, sign, and return the Reply Form; and return of any affected lot numbers of the product. The product is to be returned to ConMed Linvatec. Questions should be directed to Customer Service at 1-800-237-0169.

Device

Device Recall LIGHTWAVE SUCTION ABLATOR
  • 모델명 / 제조번호(시리얼번호)
    All lots manufactured from July 2004 to September 2008: Lot Numbers: 0407121, 0407151, 0407211, 0407271, 0411151, 0411221, 0411291, 0412081, 0412111, 0502161, 0502211, 0504281, 0505021, 0505061, 0505091, 0505101, 0505121, 0505161, 0505171, 0505231, 0506021, 0506131, 0507051, 0508121, 0508221, 0508251, 0509061, 0511021, 0511091, 0511301, 0602231, 0604241, 0606071, 0606191, 0610271, 0611011, 0703121, 0703191, 0704021, 0704091, 0704121, 0705091, 0705231, 0706041, 0706221, 0706271, 0707241, 0708031, 0708131, 0708201, 0711261, 0711301, 0801072, 0801152, 0802132, 0802202, 0803072, 0803112, 0803262, 0803312, 0804171, 0804292, 0805022, 0805061, 0805062, 0806092, 0806262, 0807142, 0807232, 0807292, 0808052, 0808132, 0809032, 0809052, and 0809262.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution
  • 제품 설명
    REF IA-2000-S, LightWave Suction Ablator, STERILE, Rx ONLY, MADE IN USA. || CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908. || ConMed Linvatec LIGHTWAVE SUCTION ABLATOR, electrosurgical cutting and coagulation device and accessories, intended to remove tissue and control bleeding by use of high-frequency electrical current.
  • Manufacturer
    Linvatec Corp. dba ConMed Linvatec

Manufacturer

Linvatec Corp. dba ConMed Linvatec
  • 제조사 주소
    Linvatec Corp. dba ConMed Linvatec, 11311 Concept Blvd, Largo FL 33773-4908
  • 제조사 모회사 (2017)
    CONMED Corp.
  • Source
    USFDA