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Xio Radiation Treatment Planning System (2013-12-20)
- Starting date:
- December 20, 2013
- Posting date:
- February 11, 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-37871
Recalled products
- Xio Radiation Treatment Planning System
Reason
When the bolus is present, the effective depth (with bolus) to the weight point returned on the source data report is incorrect. The problem occurs when the bolus polygon incorrectly invades the patient contour and overlaps an area where the CT density is much different than bolus density. This is more likely to occur with convex patient surfaces.
Affected products
A. Xio Radiation Treatment Planning System
Lot or serial number
- XiO Release 4.50.00
Model or catalog number
- 9200
Companies
- Manufacturer
-
Elekta Business Area Software Systems Impac Medical Systems Inc.
13723 Riverport Drive, Suite 100
Maryland Heights
63043
Missouri
UNITED STATES