Events

Recall of OrthoScan Mini C-Arm X-Ray Systems Multiple Affected Model and Serial Numbers

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medical & Optical Instruments Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2018-RN-00339-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-04-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00339-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    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