Events

Rappel de OrthoScan Mini C-Arm X-Ray Systems Multiple Affected Model and Serial Numbers

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Medical & Optical Instruments Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2018-RN-00339-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-04-24
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00339-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    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