Events

OrthoScan Mini C-Arm X-Ray Systems Multiple Affected Model and Serial Numbers 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Medical & Optical Instruments Australia 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-2018-RN-00339-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-04-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00339-1
  • 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, orthoscan, has identified that the device does not fully meet the requirements of iec en 60601-2-54 with respect to specified workflows and the use of digital zoom mode. the system software allows a user to activate the digital zoom feature in the course of taking a live image exposing a larger x-ray field than can be viewed by the user. to date, there are no reports of injury as a result of this issue.
  • 조치
    Medical + Optical Instruments is advising that they will be in contact with customers to arrange installation of a new software version which will restore compliance of the device. In the interim, users may continue to use their affected system by taking the following measures: · When visualizing the image with magnification, users should only select Digital Zoom as part of a post image capture operation whereby the Fluoroscopic X-ray beam is not active; · Alert all staff members working with the device that they should never select the Digital Zoom while the Fluoroscopic x-ray beam is active; · Staff are familiarised with the proper workflows to avoid the potential hazard of selecting Digital Zoom when the Fluoroscopic x-ray beam is active.

Device

OrthoScan Mini C-Arm X-Ray Systems Multiple Affected Model and Serial Numbers
  • 모델명 / 제조번호(시리얼번호)
    OrthoScan Mini C-Arm X-Ray Systems Multiple Affected Model and Serial NumbersARTG Number: 157136(Medical & Optical Instruments Australia - X-ray system, diagnostic, fluoroscopic, general-purpose, portable, digital)
  • Manufacturer
    Medical & Optical Instruments Australia Pty Ltd

Manufacturer

Medical & Optical Instruments Australia Pty Ltd