Device Recall Lamp, surgical 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 MAQUET 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
    51297
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1154-2009
  • 사례 시작날짜
    2009-02-23
  • 사례 출판 날짜
    2009-04-12
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2009-09-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    ALM SURGICAL LAMPS - Product Code FTD
  • 원인
    The screws holding the prismatic triple surgical lights may break due to dynamic multidirectional bending stress. the firm has received one complaint report.
  • 조치
    An "Urgent Device Correction" letter dated February 23, 2009 was mailed by FedEx Tracking to all affected consignees. The letter described the issue, potential hazard and recommended precaution. Customers were instructed to complete the enclosed "Customer Response Fax Form" and return it via fax (1-732-667-1903) to Maquet, Inc. Maquet, Inc. will schedule repair service of the affected units once the "Customer Response Fax Form" is received. Direct questions to your local Maquet, Inc. Representative.

Device

  • 모델명 / 제조번호(시리얼번호)
    Article Number: 567030999; Serial Numbers: 6041, 6042, 6043, 6044, 6045, 6046, 6047, 6048, 6049, 6050, 6051, 6052, 6053, 6054, 6057, 6058, 6059, 6060, 6061 and 6062.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Alm Prismatic Surgical Light 5004 SF; || Maquet SA. || ALM PRISMATIC (PRC) Surgical Lights are used to provide visible illumination for the surgical field or for the examination of the patient. PRC is designed to eliminate shadow, reduce reflected heat, and illuminate surgical incisions of all depths during surgical procedures.
  • Manufacturer

Manufacturer

  • 제조사 주소
    MAQUET Inc., 1140 US Highway 22 East, Suite 202, Bridgewater NJ 08807-2958
  • 제조사 모회사 (2017)
  • Source
    USFDA