Device Recall Bausch & Lomb Stellaris Vision Enhancement System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Bausch & Lomb 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
    54268
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1664-2010
  • 사례 시작날짜
    2010-01-15
  • 사례 출판 날짜
    2010-05-26
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2013-05-17
  • 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
    instrument, vitreous aspiration and cutting, ac-powered cord - Product Code NFJ
  • 원인
    The ac power cords used on these products are subject to an fda alert -- safety investigation of certain medical device power cords: initial communication, date issued: october 19, 2009.
  • 조치
    A "URGENT: POWER CORD RECALL" letter and copies of the FDA Alert dated Oct. 19, 2009 were sent to all customers on or about Jan. 15, 2010, by Stericycle, a recall notification service. The letter describes the product, problem and actions to be taken by the customers as well as FDA's recommendations and actions. The customers were made aware of the FDA Alert concerning the AC power cords and notified that these power cords were used in the devices. They were requested to inspect the power cords for damage and notify the recalling firm if damage is noted or if they have experienced sparking, charring, or firing from the power cords and/or cracking or failure of the prongs. In the absence of those conditions, customers were given the option of returning the power cord for replacement and/or during the regularly scheduled servicing of the device. If you would like a new power cord, please contact Customer Service at 1-800-338-2020 for a free replacement.

Device

  • 모델명 / 제조번호(시리얼번호)
    All devices manufactured since 2004
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: United States & Puerto Rico; Venezuela, India, Trinidad and Tobago, Colombia, Sri Lanka, Hong Kong, Vietnam, and Peru.
  • 제품 설명
    Bausch & Lomb Stellaris Vision Enhancement System.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Bausch & Lomb Inc, 1400 North Goodman Street, Rochester NY 14609-3547
  • Source
    USFDA