Events

Device Recall Wall Mounting Plate 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Gendex Dental Systems 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
    57500
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1559-2011
  • 사례 시작날짜
    2010-12-20
  • 사례 출판 날짜
    2011-03-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96390
  • 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
    Unit, x-ray, extraoral with timer - Product Code EHD
  • 원인
    The x-ray unit may break loose from the mounting plate and fall off the wall due to defects in the mounting plate.
  • 조치
    The firm, Gendex, sent an "URGENT MEDICAL DEVICE FIELD CORRECTION" letter dated December 20, 2010 to their customers. A revised notification letter dated January 20, 2011, was sent to the customers providing further clarification on instruction to correct the problem, as well as a template for end user notification. The letters described the product, problem and actions to be taken. The customers were instructed to contact their customers, inform them of the issue and replace the wall-mounting plate. The customers were also instructed to complete and return the attached acknowledgement form via fax to 215-997-5665 Attn: Regulatory Affairs or email to: regulatory.affairs@gendex.com and contact Gendex Customer Service at 1-800-323-8029. If you have any questions or concerns, contact the Regulatory Affairs Associate at 847-364-3290 or regulatory.affairs@gendex.com.

Device

Device Recall Wall Mounting Plate
  • 모델명 / 제조번호(시리얼번호)
    part numbers D800WPEXPERT, D800WP, EXPERTDC55 NAWP, EXPERTDC65 NAWP and EXPERTDC75 NAWP distributed between April 12, 2010 and May 13, 2010
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA and countries including: Australia, Canada and Germany.
  • 제품 설명
    Wall Mounting Plate, an accessory to the Gendex eXpert DC (REF 110-0205G1) and 765DC (REF 110-0155G1)Intraoral X-Ray Systems; Gendex Dental Systems, Des Plaines, IL USA || The wall mounting plate is used to install the Master Control unit of the X-ray system to two wooden wall studs spaced at 16", or to a wall supported by steel studs.
  • Manufacturer
    Gendex Dental Systems

Manufacturer

Gendex Dental Systems
  • 제조사 주소
    Gendex Dental Systems, 901 W Oakton St, Des Plaines IL 60018-1843
  • Source
    USFDA