eFilm Workstation 4.0 and eFilm Workstation 4.0.1 (2014-08-28)

Starting date:

August 28, 2014

Posting date:

November 21, 2014

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-42229

• 
  Reason
• 
  Affected products

Recalled products   

1. eFilm Workstation 4.0 and eFilm Workstation 4.0.1 

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.

Affected products