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GEM Flex Coil and Interface P-Connector (2016-02-15)
- Starting date:
- February 15, 2016
- Posting date:
- February 22, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-57206
Affected Products
- GEM FLEX COIL 3.0T RECEIVE ONLY
- GEM FLEX INTERFACE 16CH FIXED, 3.0T P-CONNECTOR
Reason
Part of the cable assembly may overheat when the device is used. Rarely this could result in minor burn injury in case of prolonged direct skin contact with the overheating part. There have been no injuries reported as a result of this issue.
Affected products
-
GEM FLEX COIL 3.0T RECEIVE ONLY
Lot or serial number
0000033-4-0044
0000034-4-0037
0000040-4-0033
033-4-0277
033-4-0314
034-4-0255
034-4-0296
040-4-0020
040-4-0275
040-4-0315
Model or catalog number
NC033000
NC034000
NC040000
Companies
- Manufacturer
-
Neocoil
N27 W23910A PAUL ROAD
PEWAUKEE
Wisconsin
UNITED STATES
B. GEM FLEX INTERFACE 16CH FIXED, 3.0T P-CONNECTOR
Lot or serial number
000032E-4-0041
032E-4-0330
032E-4-0336
032E-4-0394
Model or catalog number
NC032004
Companies
- Manufacturer
-
Neocoil
N27 W23910A PAUL ROAD
PEWAUKEE
Wisconsin
UNITED STATES