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RAYSTATION
- Starting date:
- September 1, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-60358
Affected Products
Reason
When a region of interest (ROI) with material override overlaps a fixation or support ROI, the material used for dose calculation in the overlapping region may not be as intended. Also, when a support or fixation ROI overlaps the patient outline (external ROI) in a dose grid voxel along the outer surface of the patient outline, the density used for dose calculation in that voxel may not be as intended.
Affected products
RAYSTATION
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
2.5
3.0
4.0
4.5
4.7
Companies
- Manufacturer
-
Raysearch Laboratories AB,
Sveavagen 25,
Stockholm
11134
SWEDEN