Signa, Discovery and Optima MRI Systems (2014-12-29)

Starting date:

December 29, 2014

Posting date:

January 7, 2015

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-43157

• Reason
• Affected products

Recalled Products

A) 1.5T Signa Horizon MRI System
B) Signa 1.5T Excite HD Magne - MRI System
C) 3.0T Signa HDX MRI System
D) 1.5T Signa HDX MRI System
E) Discovery MR750 MRI system.
F) 1.5T Signa Infinity Twinspeed with Excite MRI Syst
G) Signa 1.5T Infinity Excite MRI System
H) Signa HDXT 1.5T MRI System
I) Discovery MR450 1.5T MRI System
J) Signa HDI 1.5 T MRI System -16 channel mobile
K) Optima MR450W -16CH MRi System
L) Optima MR450W -32CH MRI System
M) Optima MR450W -GEM MRI System

Reason

Magnet Rundown Unit (MRU) may not be connected to the magnet. If the MRU is disconnected, the MRU will not function as expected and will not quench the magnet when the button is pressed. In emergency situations, a disconnected MRU could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries. The MRU must be connected to the magnet at all times.

Affected products