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Focal Software CD (2014-12-19)
- Starting date:
- December 19, 2014
- Posting date:
- December 29, 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-43041
Recalled Products
Focal Software CD
Reason
In the case where CT slice thickness is not the same as CT slice spacing the image statistics tool will report an incorrect HU. If the user bases their CT to ED file on this incorrect density information, dose calculation errors will result. The magnitude of the dose calculation error will be dependent on the magnitude of the HU error.
Affected products
Focal Software CD
Lot or serial number
Not applicable
Model or catalog number
FOCAL SIM
Companies
- Manufacturer
-
Elekta Business Area Software Systems Impac Medical Systems Inc.
13723 Riverport Drive, Suite 100
Maryland Heights
63043
Missouri
UNITED STATES