Device Recall Orthoralix 8500 DDE Panoramic 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
    57888
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2040-2011
  • 사례 시작날짜
    2011-02-04
  • 사례 출판 날짜
    2011-04-22
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-02-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    There is an anomaly in the orthoralix firmware which can cause a message corruption which will distort the patient image being transferred from the x-ray system to the pc. this image distortion/corruption (distorted, fragmented, flipped, negative, reversed or had lines across them) is most likely to occur during periods of high network traffic and is significant enough that it is clear and obviou.
  • 조치
    Gendex sent a recall letter to their accounts on February 4, 2011 via first class mail, stating that an anomaly in the Orthoralix firmware can cause a message corruption which will distort the patient image being transferred from the X-Ray system to the PC. This image distortion/corruption (distorted, fragmented, flipped, negative, reversed or had lines across them) is most likely to occur during periods of high network traffic and is significant enough that it is clear and obvious these images cannot be used for diagnostic purposes. The letter stated that resending the image from the X-Ray system to the PC will correct the issue present in certain images sent during periods of high network traffic. Instructions were provided to download an Appendix to Orthoralix DDE User Manual that explains how to resend the images. If that does not resolve the issue, users were requested to contact Gendex Technical Support at 1-800-323-8029. Customers were asked to complete and return the enclosed Acknowledgement Form by fax to 215-997-5665 or e-mail: regulatoryaffairs@gendex.com. For questions regarding this recall call 800-323-8029.

Device

  • 모델명 / 제조번호(시리얼번호)
    Part numbers 110-0199G2, 110-0199G4, 110-0234G1 and 110-0234G3 and all serial numbers .
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution--United States, including Puerto Rico, Australia, Canada, Chile, Colombia, Germany, Hong Kong, India, Italy, Korea, Mexico, New Zealand, Peru, Singapore, Taiwan and Vietnam.
  • 제품 설명
    Orthoralix 8500 DDE Panoramic Dental X-Ray System; Extraoral x-ray unit with timer; Gendex Dental Systems, Des Plaines, IL 60018; part numbers 110-0199G2, 110-0199G4, 110-0234G1 and 110-0234G3. || The intended use of the device is to be used as an extraoral source of x-rays for imaging of the dento-maxillo-facial area.
  • Manufacturer

Manufacturer

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