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MONACO
- Starting date:
- January 10, 2017
- Posting date:
- January 25, 2017
- 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-61950
Reason
Calculated dose from wedged beams can be assigned to the wrong beam. This can occur for a plan with at least two beams using the Elekta Motorized Wedge. The user must change the beam index numbers belonging to the two wedged beams, such that the index numbers have been exchanged for these beams, then edit the wedge angle of one of the beams. The beam index numbers are located in the first column of the beams spreadsheet.
Affected products
MONACO
Lot or serial number
- Version 5.10.01
- Version 5.10.02
- Version 5.11.01
- Version 5.20.00
Model or catalog number
MONACO
Companies
- Manufacturer
-
Elekta Business Area Software Systems Impac Medical Systems, Inc.
13723 RIVERPORT DRIVE SUITE 100
Maryland Heights
63043
UNITED STATES