Vatech X-Ray System, models: Pax-500, Pax-Uni3D, pax-Reve3D and Duo3D and Picasso 3D (Dental x-ray system)Manufactured between 15 May 2009 and 15 July 2009. 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Vatech Medical Pty Ltd 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
    RC-2012-RN-01219-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-12-04
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    The manufacturer has identified these products as possibly having a faulty coupling spacer. the coupling spacer used during this period was made out of plastic and in some instances the plastic spacer can break. when the coupling spacer is damaged, the column shaft will make a noisy sound when the operator continues to adjust the up/down switch.This recall action was not notified to the tga before it was initiated by vatech medical.
  • 조치
    The sponsor is providing users with work around instructions and will be replacing the spacers on all affected devices.

Device

  • 모델명 / 제조번호(시리얼번호)
    Vatech X-Ray System, models: Pax-500, Pax-Uni3D, pax-Reve3D and Duo3D and Picasso 3D (Dental x-ray system)Manufactured between 15 May 2009 and 15 July 2009. ARTG Number: 199091
  • Manufacturer

Manufacturer