Events

Osseocare Pro Console & Set Osseocare Pro 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Nobel Biocare Usa Llc 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
    66664
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0273-2014
  • 사례 시작날짜
    2013-10-24
  • 사례 출판 날짜
    2013-11-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-04-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122918
  • 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
    Controller, foot, handpiece and cord - Product Code EBW
  • 원인
    The recall was initiated because there is a potential for malfunction of the osseocare pro when used with the oseeocare pro ipad application software release 1.2.0.7.
  • 조치
    Bien Air Dental send and Urgent Field Safety Notice dated October 24, 2013, to all affected customers. The letter notified customers of the recall, description of the problem, description of the product (OsseoCare Pro iPad app software release 1.2.0.7), action to be taken by user, an alternative solution, and contact details. The letter was also accompanied by an acknowlegement form. Customers with questions were instructed to call 1-800-433-2436. For questions regarding this recall call 714-282-4800.

Device

Osseocare Pro Console & Set Osseocare Pro
  • 모델명 / 제조번호(시리얼번호)
    Model Numbers: 1600870-001, 1700470-001, 1700471-001.
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) United States and Internationally to Austria, Belgium, Brazil, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Ireland, Italy, Japan, Latvia, Lithuania, Luxembourg, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Romania, Russia, South Africa, Spain, Sweden, Switzerland, Turkey, and the United Kingdom.
  • 제품 설명
    Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. || Device Name: Osseocare Pro console & Set Osseocare Pro. || Model: 1600870-001, 1700470-001, 1700471-001. || Marketing status: Class I, under K092214. || Device description: Software-based, electronically controlled tabletop device. || In dentistry for dental surgery, endodontics and implantology.
  • Manufacturer
    Nobel Biocare Usa Llc

Manufacturer

Nobel Biocare Usa Llc
  • 제조사 주소
    Nobel Biocare Usa Llc, 22715/22725 Savi Ranch Pkwy, Yorba Linda CA 92887
  • 제조사 모회사 (2017)
    Danaher Corporation
  • Source
    USFDA