Device Recall KIT,DISPOSABLE ACCESSORY 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Intuitive Surgical, 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
    62553
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2103-2012
  • 사례 시작날짜
    2012-07-13
  • 사례 출판 날짜
    2012-07-27
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2013-06-12
  • 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
    System,surgical,computer controlled instrument - Product Code NAY
  • 원인
    Specific lots of the instrument arm drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.
  • 조치
    Intuitive Surgical sent an Urgent Medical Device Correction letters dated July 16, 2012 via Fed Ex to all affected customers in the US. The customers outside of the US were notified starting July 17, 2012. The letter identified the affected products, problem and actions to be taken. Customers were instructed to Identify affected lots, order replacement products and return both full and partial boxes of the affected products for credit as soon as unaffected products are available. All staff should be made aware of the issue. Customers were instructed to complete and return the acknowledgement form immediately. Questions and concerns should be directed to Intuitive Customer Service at 1-800-876-1310. EXPANSION: Intuitive discovered an additional lot (Lot DA121075) of Instrument Arm Drape IS2000, 20 pack that should have been included in the recall and expanded the recall on September 4, 2012. Letters to customers were sent by Fed Ex on September 5, 2012.

Device

  • 모델명 / 제조번호(시리얼번호)
    Part number: 420258-01 Lot numbers: D120755 ,D120755A , D120825.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide and the countries of: Australia, Spain, India, Italy and Saudi Arabia.
  • 제품 설명
    KIT,DISPOSABLE ACCESSORY,4ARM,IS2000,5 PACK; || Product Usage: || The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Intuitive Surgical, Inc., 1266 Kifer Rd Bldg 100, Sunnyvale CA 94086-5304
  • 제조사 모회사 (2017)
  • Source
    USFDA