This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
XIO RADIATION TREATMENT PLANNING SYSTEM (2015-08-28)
- Starting date:
- August 28, 2015
- Posting date:
- October 14, 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-55332
Affected Products
XIO RADIATION TREATMENT PLANNING SYSTEM
Reason
The manufacturer has discovered that XiO will calculate wedge dose in the region outside of the physical and the LINAC will deliver open dose. The patient will receive dose that is different from the planned dose and that dose difference can exceed 5%. There is a remote probability of serious injury resulting from this issue.
Affected products
XIO RADIATION TREATMENT PLANNING SYSTEM
Lot or serial number
Version 4.51 or higher
Model or catalog number
9200
Companies
- Manufacturer
-
Elekta Business Area Software Systems Impac Medical Systems, Inc.
13723 RIVERPORT DRIVE
SUITE 100
Maryland Heights
63043
UNITED STATES