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Pinnacle 3 Radiaion Therapy Planning System - SmartArc Module (July 30, 2013)
- Starting date:
- July 30, 2013
- Posting date:
- July 30, 2013
- 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-35385
Reason
Under certain conditions in Pinnacle 9, 9.2, and 9.4, the customer can modify the geometry of a beam or change the parameters for a bolus and the software does not invalidate the control point dose. This occurs in two situations:
1) The customer sets the 'speed up collimator movements' field in the beam's eye view options window to yes, sets the 'store control point dose' field in the control points window to yes, computes dose for a beam that uses control points, and then uses the collimator tool to adjust the collimator or jaw positions.
2) The customer sets the 'store control point dose' field in the control points window to yes, computes dose on a beam that uses control points and bolus, and then changes a parameter for a bolus that is applied to that beam.
Affected products
Pinnacle 3 Radiaion Therapy Planning System - SmartArc Module (2013-07-30)
Lot or serial number
Not applicable
Model or catalog number
4535 604 46041
Companies
- Manufacturer
- Not Applicable
- Date modified: