SIGNA Pioneer

Starting date:

August 26, 2016

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-60252

• Reason
• Affected products

Affected Products

SIGNA Pioneer

Reason

The following issue is being addressed by GE Healthcare file no. FMI 60903. Images may exhibit novel artifacts on magic T2 flair synthetic reconstructions that may be difficult to recognize without access to conventional T2 flair weighted images. This issue has the potential to lead to misinterpretation of the Magic Images when making medical diagnosis or treatment decisions. Magic Acquisition is unique in that all contrasts are acquired simultaneously, therefore any gross patient motion will impact all generated images and may further alter the presentation of the aforementioned novel artifacts. There have been no injuries reported as a result of this issue.

Affected products