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Monaco (March 16, 2012)
- Starting date:
- March 16, 2012
- Posting date:
- April 02, 2012
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-72466
Reason
When an IMRT template is selected for a new patient, DRP points can be placed in a region where the dose is zero. If the rescale dose function is invoked, the Total Dose, MU, DVH, Isodoses and Dose Cursor remain unscaled but agree, but individual beam doses are scaled. If the beam doses are used for a plan evaluation, this dose will not agree with the rest of the plan dose (Total Dose, MU, DVH, Isodoses, etc.) and incorrect clinical decisions could be made.
Affected products
Monaco(2012-03-16)
Lot or serial number
Version 3.10.00
Model or catalog number
Monaco
Companies
- Manufacturer
- Not Applicable
- Date modified: