Events

Bluephase Style Light Pin Point Probe 62 mm 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ivoclar Vivadent, 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
    67998
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1740-2014
  • 사례 시작날짜
    2014-04-14
  • 사례 출판 날짜
    2014-06-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-11-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126760
  • 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
    Activator, ultraviolet, for polymerization - Product Code EBZ
  • 원인
    A stock check revealed broken glass fibers between the connector and the fiber bundle in a large number of these light probes.
  • 조치
    lvoclar Vivadent, Inc. sells the affected medical device through Dental Dealer partners (initial consignees) who in turn sell directly to the dentist's office. In this case, lvoclar Vivadent, Inc. handled direct drop shipment of the device to end user dental offices in 80% of the cases. Where lvoclar Vivadent has direct shipment information available, dentist offices will be notified directly. The Dental Dealer partners will be notified of this recall and asked to cooperate and provide name and address listings for all dental office customers where they have shipped the Pin Point probe. The dealer will also be given a customer communication to send directly to the dentists purchasing the device.

Device

Bluephase Style Light Pin Point Probe 62 mm
  • 모델명 / 제조번호(시리얼번호)
    Reference number 636241, all lots
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US Nationwide and the country of Canada.
  • 제품 설명
    bluephase style Light probe Pin-point 6>2 mm black REF # 636 241. The accessory is a pin point light probe, an accessory to a dental curing light || Ultraviolet activator for polymerization for use during dental curing.
  • Manufacturer
    Ivoclar Vivadent, Inc.

Manufacturer

Ivoclar Vivadent, Inc.