Events

Device Recall Gendex eXpert DC Intraoral Dental XRay System 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
    61295
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1358-2012
  • 사례 시작날짜
    2011-12-29
  • 사례 출판 날짜
    2012-04-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-06-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107747
  • 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
    Improper hardware was used during installation of the expert dc intraoral x-ray system units causing drifting of the tubehead assembly.
  • 조치
    Gendex Dental Systems sent a Urgent Medical Device Correction letter dated December 29, 2011, to both affected customers. The Customers were provided background information and details on how the nonconforming installations of the devices would be corrected. Gendex Dental Systems apologizes for any inconvenience caused by this issue, and request your corporation as we correct this problem. The customers were instructed to complete and return the Acknowledgement Form upon receipt of the recall notification letter and fax to (215) 997-5665. For further questions please call (215) 954-0365.

Device

Device Recall Gendex eXpert DC Intraoral Dental XRay System
  • 모델명 / 제조번호(시리얼번호)
    Model # EXPERTDC75NA, serial numbers 2007017, 2006983, 2007018, 2006982, 2003916, 2007015, 2007051, 2007021, 2006975, 2003900, 2006987, 2007027, 2006989, 2003812, 2007024, 2006985, 2006986, 2006980, 2007025, 2007026, 2006979, 2006976, 2003840, 2003906, 2003820, 2006977, 2007023, 2006978, 2003917, 2003907, 2003904, 2007028, 2007022, 2007019, 2003829, 2003876, 2003909, 2003920, 2003862, 2007029, 2007016, 2003937, 2003877, 2007020, 2003835, 2003908; model # EXPERTDC55NA, serial numbers 2004394, 2004396, 2004437, 2004430, 2004436, 2004416
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    USA including the states of Iowa and Illinois.
  • 제품 설명
    Gendex eXpert DC Intraoral Dental X-Ray System || Device is to be used as an extra-oral source of X-Rays in Dental Radiography
  • Manufacturer
    Gendex Dental Systems

Manufacturer

Gendex Dental Systems
  • 제조사 주소
    Gendex Dental Systems, 1910 N Penn Rd, Hatfield PA 19440-1959
  • Source
    USFDA