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Monaco (2014-08-18)
- Starting date:
- August 18, 2014
- Posting date:
- August 25, 2014
- 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-41173
Recalled Products
Monaco
Reason
Areas that should receive no dose may be treated and areas that are supposed to be treated may receive more or less dose than they should. The Dicom exported plan and subsequent treatment delivery will not match the approved treatment plan. There is a remote probability of the issue resulting in serious adverse health consequences.
Affected products
Monaco
Lot or serial number
Version 3.2 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