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Discovery MR450 Narrow Bore 1.5T MRI
- Starting date:
- January 26, 2017
- Posting date:
- February 9, 2017
- 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-62136
Reason
Potential safety issue with the patient bore heating on the Discovery MR450 Narrow Bore 1.5T MRI. In the event of radio frequence (RF) component failure, typically happening after extended system use, a small area on the bore surface may become warmer than normal. If this happens in an area where there is patient contact with the bore, and proper padding is not used, it may cause a serious burn.
Affected products
Discovery MR450 Narrow Bore 1.5T MRI
Lot or serial number
- 000000000R7149
- 000000000R7320
- 00000944BD616B
- 00001101XF5028
Model or catalog number
- DISCOVERY MR450 1.5T MR SYSTEM
Companies
- Manufacturer
-
GE Medical Systems LLC
3200 North Grandview Blvd
Waukesha
53188
Wisconsin
UNITED STATES