Events

Recall of EFILM WORKSTATION

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MERGE HEALTHCARE INCORPORATED.

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
    53353
  • Event Risk Class
    III
  • Event Initiated Date
    2014-09-19
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    On august 11 2014 a customer in another country reported that when working with multiple studies and using thumbnail panels (i.E. using a very specific workflow) the thumbnail tab changed unexpectedly. the radiologist noticed a flicker on the screen and checked the dicom study information displayed on the image. he realized that it was not the study that he had intended to add to the viewport and thus avoided dictating a report based on the wrong study. no patients were affected. upon investigation a problem was discovered where the efilm workstation software may cause the user interface for the thumbnail panel tabs to refresh and to switch tabs. if the user does not notice this it may result in the selection of a different series than the one the user intended to add (by dragging thumbnails down from the thumbnail panel) to the viewing panes in the main screen. additionally when tabs are switched selected image highlighting in the thumbnail panel may incorrectly highlight a series that does not match the series in the viewport. note that the user must look at the date on the image to confirm that the correct image series or study is being reviewed. the date information on the images is correct and is not affected by this problem.

Device

EFILM WORKSTATION
  • Model / Serial
    Model Catalog: EFILM01 (Lot serial: N/A)
  • Product Description
    EFILM WORKSTATION 4.0 AND EFILM WORKSTATION 4.0.1
  • Manufacturer
    MERGE HEALTHCARE INCORPORATED

Manufacturer

MERGE HEALTHCARE INCORPORATED