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Cadstream
- Starting date:
- August 26, 2016
- 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-60226
Affected Products
Cadstream
Reason
This recall has been initiated due to a necessary modification to the Cadstream difference threshold when Cadstream is used in conjunction with the GE Phased Array Uniformity Enhancement (Pure) for dynamic MRI imaging and a lack of notification when Cadstream detects the pure filter has been used.
Affected products
Cadstream
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
CADSTREAM
Companies
- Manufacturer
-
Merge Healthcare Incorporated,
900 Walnut Ridge Drive,
Hartland
53029
Wisconsin
UNITED STATES