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MSK Extreme and Optima MR430S 1.5T 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-43103
Recalled Products
A) MSK Extreme - MRI System
B) Optima MR430S 1.5T - 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
A) MSK Extreme - MRI System
Lot or serial number
905521ONI
Model or catalog number
AB2000
Companies
- Manufacturer
-
GE Medical Systems, LLC
301 Ballardvale St., Suite 4,
Wilmington
01887
Massachusetts
UNITED STATES
B) Optima MR430S 1.5T - MRI System
Lot or serial number
514697ONI
Model or catalog number
OPTIMA MR430S 1.5T (5000-0002)
Companies
- Manufacturer
-
GE Medical Systems, LLC
301 Ballardvale St., Suite 4,
Wilmington
01887
Massachusetts
UNITED STATES