Events

Integra LifeSciences 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Integra LifeSciences Corp. 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
    60300
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0356-2012
  • 사례 시작날짜
    2011-10-14
  • 사례 출판 날짜
    2011-12-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-03-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104989
  • 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
    Light source, fiberoptic, routine - Product Code FCW
  • 원인
    A loose screw may result in shifting of components and improper function of the turret or actuator assembly.
  • 조치
    Integra sent an URGENT: Field Corrective Action letter dated October 14, 2011 to all affected customers via FedEx. The letter identified the affected product, the problem, and the actions to be taken with instructions to immediately inspect their inventory for potentially loose screws within the affected unit(s). If the unit(s) were observed with loose screws, the unit(s) were to be returned to Integra Surgical for repair and servicing. Customers were instructed to complete the Acknowledgement and Return Form per the instructions on the form. For questions call Integra Surgical Customer Service at 1-800-431-1123.

Device

Integra LifeSciences
  • 모델명 / 제조번호(시리얼번호)
    SN'S: P0103111 P0105711 P0106011 P0200111 P0200211 P0201111 P0201611 P0201811 P0202011 P0202111 P0202911 P0203111 P0203411 P0203711 P0203811 P0204011 P0204211 P0204311 P0204411 P0204611 P0204711 P0204811 P0204911 P0205211 P0205411 P0205511 P0205711 P0205611 P0205811 P0205911 P0206211 P0206311 P0206411 P0210711 P0212911 P0213811 P0213911 P0300211 P0300411 P0300711 P0300911 P0301011 P0301411 P0301511 P0301711 P0301811 P0302111 P0302311 P0302411 P0302511 P0302611 P0302711 P0302811 P0303011 P0303111 P0303211 P0303311 P0303511 P0303611 P0303711 P0304011 P0304111 P0304311 P0304411 P0304611
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) including the states of: Arizona, California, Colorado, Florida, Indiana, Mississippi, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Montana, Washington, Wyoming, and Puerto Rico, and the countries of: Australia, Germany, Italy, Japan, Netherlands, New Zealand, Pakistan, Sweden, Switzerland, and Turkey.
  • 제품 설명
    Integra Surgical Luxtec MLX Light Source || Catalog Numbers: 00MLX || Product Usage: The Integra Luxtec MLX Light Source is designed to supply high intensity white light through a fiber optic cable for illumination of a surgical field during a surgical and or medical procedure.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.