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Oncentra External Beam/Oncentral Brachy 4.5
- Starting date:
- December 23, 2016
- Posting date:
- January 12, 2017
- 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-61766
Reason
If a physical wedge, for which the total field size limit perpendicular to the wedge direction is more than 10 cm larger than the field size limit in wedge direction, is inserted in in-plane direction (as seen with collimator angle 0 degrees), then with very large fields perpendicular to wedge direction a part of the scattered fluence can become unmodulated by the wedge. This will result in profile "horns" close to the edge of the field.
Affected products
Oncentra External Beam/Oncentral Brachy 4.5
Lot or serial number
Version 4.5.X
Model or catalog number
170.730
Companies
- Manufacturer
-
Nucletron B.V.
Waardgelder 1
Veenedaal
3905 TH
NETHERLANDS