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MONACO (2015-09-15)
- Starting date:
- September 15, 2015
- Posting date:
- October 5, 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-55210
Affected Products
MONACO
Reason
Two issues affecting the Monaco device: 1) when CT images are created this latter way and imported in Monaco, the image is displayed correctly but the electron densities are incorrectly flipped in both the right-left and superior-inferior directions. 2) when using multiple prescription and the first prescription has forced densities, these forced densities are not being maintained with the second prescription.
Affected products
MONACO
Lot or serial number
Not applicable
Model or catalog number
MONACO
Companies
- Manufacturer
-
Elekta Business Area Software Systems Impac Medical Systems
Inc.
13723 Riverport Drive
Missouri
UNITED STATES