Intellispace Portal (2014-07-30)

Starting date:

July 30, 2014

Posting date:

August 25, 2014

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-41179

• Reason
• Affected products

Recalled Products

Intellispace Portal 

Reason

There are software issues in the affected product.

1. When reopening a bookmark generated from processing a multi-gated acquisition (MUGA) scan within the nm cardiac application, the ejection fraction (EF) may be different.
2. When processing using one of the following nm clinical applications: Autoquant, Emory cardiac toolbox, Corridor4 DM, or Neuroq, the patient study presented to the reviewing physician within the application may be for a different patient than the one selected from the patient directory. Note: the data presented to the reviewing physician is the data for the patient presented by the application labeling.
3. While using the NM viewer application, an arrow annotation added to a display moves away from its original position if the viewer is subsequently maximized or if the image within the viewer is subsequently zoomed in or out.
4. While displaying pet images within CT viewer, the SUV results displayed may be calculated with a SUV method different from the one specified in system preferences. This issue affects the CT viewer and multi-modality tumor tracking applications.

Affected products