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PHASED ARRAY FLEX COIL (2015-12-10)
- Starting date:
- December 10, 2015
- Posting date:
- December 24, 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-56468
Recalled Products
A. PHASED ARRAY FLEX COIL
Reason
Coil overheating can occur when the device is used in mode 2 setup. This could lead to a serious patient thermal injury. There have been no injuries reported as a result of this issue.
Affected products
A. PHASED ARRAY FLEX COIL
Lot or serial number
0000011-4-0019
0000011-4-0020
011-4-0128
11-4-0127
Model or catalog number
5363393
Companies
- Manufacturer
-
GE Medical Systems LLC
3200 North Grandview Blvd
Waukesha
53188
Wisconsin
UNITED STATES