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MONACO (2015-10-14)
- Starting 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-55712
Affected Products
MONACO
Reason
When the 100% isodose value is edited on the isodose control, the dose normalization is automatically updated. If the user does not notice this update and then rescales to the relative isoline and does not read the dose normalization value displayed on the rescale bar, the rescale could be other than intended. When the user optimizes, then changes the bolus assigment of the beams, and then selects "calculate" (not "optimize" again), the bolus assignment to beams can get scrambled.
Affected products
MONACO
Lot or serial number
Version 5.10.00 and higher
Model or catalog number
MONACO
Companies
- Manufacturer
-
Elekta Business Area Software Systems Impac Medical Systems, Inc.
13723 RIVERPORT DRIVE SUITE 100
Maryland Heights
63043
Missouri
UNITED STATES