Events

Device Recall Dental chair headrest 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Dental Equipment 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
    55153
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2241-2010
  • 사례 시작날짜
    2010-03-23
  • 사례 출판 날짜
    2010-08-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-01-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90151
  • 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
    Dental chair headrest - Product Code NRU
  • 원인
    The magnetic headrest on certain dental chairs may affect the function/programming of some implantable pacemakers or defibrillators if the implanted device is programmed to respond to a magnet.
  • 조치
    DCI Equipment sent an "Urgent Field Safety Alert" letter dated March 15, 2010 to consignees advising them of the potential problem. The letter instructed that patients with implantable pacemakers or defibrillators should avoid dental chairs with the magnetic headrest. A warning label was sent with the letter for insertion into the product Use and Care manual for operator warning. Consignees were asked to complete a Field Safety Alert Acknowledgement/Return Form and fax to the firm. Consignees were requested to notify customers.Consignees may contact the firm at 503 537-3602.

Device

Device Recall Dental chair headrest
  • 모델명 / 제조번호(시리얼번호)
    The individual headrests do not have serial numbers. The headrest has a part number of "40R501". The part number is followed by a dash and a 2 or 3 digit number that indicates the color of the vinyl covering.
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution in the USA and Canada.
  • 제품 설명
    The magnetic headrest is designed to fit the following dental chairs (THE HEADREST IS THE RECALLED ITEM, NOT THE CHAIRS): || The dental chairs are sold under the brand names Marus and DCI Equipment. The affected models are: || Marus MaxStar-Agency Model # DC1490; || Marus MaxStar-Agency Model # DC1690; || Marus NuStar-Agency Model # DC1700; || Marus NuStar-Agency Model # DC1702; || Marus ProStar-Agency Model # DC1540; || Marus ProStar-Agency Model # DC1535; || DCI Equipment DC1235 Hydraulic-Agency Model # DC1235; and || DCI Equipment DC1335 Electromechanical-Agency Model # DC1335.
  • Manufacturer
    Dental Equipment LLC

Manufacturer

Dental Equipment LLC
  • 제조사 주소
    Dental Equipment LLC, 705 S Springbrook Rd Bldg B200, Newberg OR 97132-7057
  • Source
    USFDA