Events

Device Recall Mammotome EX Holster (Product Code HHEX) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ethicon Endo-Surgery 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
    30718
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0440-05
  • 사례 시작날짜
    2004-12-10
  • 사례 출판 날짜
    2005-01-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-10-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36451
  • 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
    Instrument, Biopsy - Product Code KNW
  • 원인
    A capacitor of the wrong value was used. the capacitor used was 0.11 microfarad instead of 0.22 microfarad called for in the product specifications.
  • 조치
    The recalling firm notified hospitals and distributors of the product by letter, dated 12/10/04.

Device

Device Recall Mammotome EX Holster (Product Code HHEX)
  • 모델명 / 제조번호(시리얼번호)
    HRDE39904, HRDE40502, HRDE40102, HRDE39920 HRDE40209, HRDE40204, HRDE39916, HRDE40220 HRDE39921, HRDE40114, HRDE40225, HRDE40508 HRDE40210, HRDE40222, HRDE39919, HRDE39906 HRDE40218, HRDE40724, HRDE40109, HRDE39903 HRDE40106, HRDE40118, HRDE40203, HRDE40113 HRDE40511, HRDE40206, HRDE39908, HRDE39910 HRDE40701, HRDE40513, HRDE40713, HRDE40720 HRDE40718, HRDE40710, HRDE40704, HRDE40716 HRDE40706, HRDE40520, HRDE40722, HRDE40708 HRDE40714 HRDE40522, HRDE40719, HRDE40705 HRDE40525, HRDE40527, HRDE40721, HRDE40703 HRDE40516, HRDE40725, HRDE40709, HRDE40702 HRDE40715, HRDE40518, HRDE40506, HRDE40519 HRDE40707, HRDE40712, HRDE40711, HRDE39922 HRDE40103, HRDE39901, HRDE40126, HRDE40120 HRDE39905, HRDE40723, HRDE40101, HRDE40205 HRDE40214, HRDE40526, HRDE40618, HRDE39902 HRDE40202, HRDE40122, HRDE40217, HRDE40221 HRDE40216, HRDE40624, HRDE39924, HRDE40717 HRDE40226, HRDE40503, HRDE40213, HRDE40107 HRDE40110, HRDE40524, HRDE40121, HRDE40514 HRDE39925, HRDE39909, HRDE39912, HRDE40505 HRDE40112, HRDE40212, HRDE40510, HRDE40208 HRDE40201, HRDE39907, HRDE39926, HRDE40124 HRDE40223, HRDE39923, HRDE40219, HRDE40111 HRDE40509, HRDE40515, HRDE40517, HRDE40108 HRDE39918, HRDE40521, HRDE40123, HRDE39914 HRDE39915, HRDE40501, HRDE40211 HRDE40224 HRDE40105, HRDE40207, HRDE39911, HRDE39911,  HRDE 39913
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The product was distributed to consignees located in MI, TN, IL, NC, GA, IL, CA, FL, IN, WI, TX, AR, KS, IA, OK, NY, PA, MS, KY, ME, MO, MA, VA, NJ, LA, MN, SD, UT, CO, AL, and NH. There are no foreign consignees.
  • 제품 설명
    Mammotome EX Holster
  • Manufacturer
    Ethicon Endo-Surgery

Manufacturer

Ethicon Endo-Surgery
  • 제조사 주소
    Ethicon Endo-Surgery, 4545 Creek Rd, Cincinnati OH 45242-2803
  • Source
    USFDA