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MONACO 5
- Starting date:
- November 3, 2016
- Posting date:
- November 15, 2016
- 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-61054
Affected Products
Reason
When creating 3D plans using dose weighting mode, if the user rescales the plan, selects "reset", and then changes the wedge angle, the plan dose and monitor units (MU) should be returned to the original values before the rescale. Instead, the system correctly restores the edited wedge field but incorrectly applies the scale reset value again to all other beams in the plan.
Affected products
MONACO 5
Lot or serial number
- Version 5.11
- Version 5.20
Model or catalog number
- MONACO RTP SYSTEM
Companies
- Manufacturer
-
Elekta Business Area Software Systems Impac Medical Systems, Inc.
13723 RIVERPORT DRIVE SUITE 100
Maryland Heights
63043
Missouri
UNITED STATES