CardiacVX (2013-08-23)

Starting date:

August 23, 2013

Posting date:

November 25, 2013

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-36835

• Reason
• Affected products

Recalled products

A. CardiacVX 

Reason

CardiacVX and CardiacVX Flow Report higher than actual flow values on Phase-Contrast images acquired with Magnitude Weighting Mask enabled. Note that this issue can only occur on Phase Contrast MR protocols with the Magnitude Weighting Mask option enabled. In the Fast Cine Phase-Contrast sequence, the Magnitude Weighting Mask is a user configurable option (Control Variable or CV). In the 2D Cine Phase-Contrast sequence (Non-Fast mode), Magnitude Weighting Mask is always on, and thus would always result in this issue.

The issue may result in an incorrect diagnosis if higher than actual flow values are not noticed.

Affected products