Events

Recall of Merge eFilm Workstation/eFilm Lite versions 2.1, 2.1.2, 3.0, 3.1, 3.3.5, 3.4, 4.0, 4.0.1, 4.0.2, 4.0.3 and 4.1(Picture archiving and communication system)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

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-2016-RN-01624-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-12-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01624-1
  • 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
    An issue has been identified regarding rf projection images (12 diacom sop classes). if user measures on rf image, “cal” (calibration) is not displayed & measurement is not correct, then the “cal” label is not displayed on the projection images after calibration is performed which should be present if the measurement is presented based on pixel spacing. measurements are incorrect because efilm is using the imager pixel spacing dicom tag, but it should be using the pixel spacing tag if the value for pixel spacing is present & is differing from imager pixel pacing tag. based on industry practice for projection images, if both the imager pixel spacing and pixel spacing attributes are present and differ, the pixel spacing attribute should be used and the "cal" (for calibrated) label should be displayed.A user will likely be able to notice that the measurements are not as expected. potential health consequence includes delay in patient care and/or change in recommendation for treatment.
  • Action
    Merge has released a software fix for this issue. The software can be downloaded from its website. Users are advised that they must discontinue using eFilm Workstation/eFilm Lite for viewing of projection images for the affected SOP classes listed in the customer letter until the upgrade is installed and in use.

Device

Merge eFilm Workstation/eFilm Lite versions 2.1, 2.1.2, 3.0, 3.1, 3.3.5, 3.4, 4.0, 4.0.1, 4.0.2, ...
  • Model / Serial
    Merge eFilm Workstation/eFilm Lite versions 2.1, 2.1.2, 3.0, 3.1, 3.3.5, 3.4, 4.0, 4.0.1, 4.0.2, 4.0.3 and 4.1(Picture archiving and communication system)ARTG Number: 191068
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia