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Discovery MR750W 3.0T MRI System (2014-03-28)
- Starting date:
- March 28, 2014
- Posting date:
- April 14, 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-39039
Recalled Products
Discovery MR750W 3.0T MRI System
Reason
Gradient coil electromechanical connections may loosen causing an increase in resistance. The increased resistance can lead to increasing heat during scanning which, in turn, can cause material in the rear endbell enclosure to overheat, generate smoke in the scan room, and cause some localized melting of the endbell.
Affected products
Discovery MR750W 3.0T MRI System
Lot or serial number
Not applicable
Model or catalog number
M7000NA
Companies
- Manufacturer
-
GE Healthcare Japan Corporation
7-127, Asahigaoka, 4-Chome,
Hino-shi, Tokyo
191-8503
JAPAN