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MONACO
- Starting date:
- December 21, 2016
- Posting date:
- January 12, 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-61742
Reason
Varian Enhanced Dynamic Wedges (EDW) or Siemens Virtual Wedges (VW) files can be loaded into incorrect energies using treatment unit (TU) storing. No warning or consistency checking done for EDW or VW files when adding these to the database. Treatment unit storing should not allow addition of an EDW or VW file for a certain energy beam to a collapsed cone model file for a different energy. Currently the user is not warned when there is a mismatch.
Affected products
MONACO
Lot or serial number
Version 5.00.01
Version 5.00.02
Version 5.00.03
Version 5.00.04
Version 5.10.01
Version 5.10.02
Version 5.10.04
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
Missouri
UNITED STATES