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Raystation (2014-09-17)
- Starting date:
- September 17, 2014
- Posting date:
- October 2, 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-41635
Recalled Products
Raystation
Reason
This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT has variable slice spacing. The dose grid volumetric representation of ROI can be wrong. This affects all dose-volume properties for such ROIs, including DVH, dose statistics, clinical goals and constraints or objective functions. Furthermore, if material override ROIs are used, or if the external is not represented by contours, the bug can trigger an error in the 3D dose distribution.
Affected products
Raystation
Lot or serial number
VERSION 4.0.3.4
Model or catalog number
4.0.3
Companies
- Manufacturer
-
Raysearch Laboratories AB,
Sveavagen 25,
Stockholm
11134
SWEDEN