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Oncentra External Beam/Oncentra Brachy 4.5
- Starting date:
- August 10, 2017
- Posting date:
- September 5, 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-64434
Reason
The issue is caused by the measured source paths for the following applicators: ring applicator sets, ring CT/MR applicator sets, interstitial CT/MR rings, Vienna CT/MR rings and advanced gynecological applicator - Venezia with lunar-shaped ovoids, which have a source step size of 2.5 mm for the Microselectron Afterloader. If you use such an applicator model to create a plan, while the default step size of the Afterloader is 5.0, the step size in the ring or lunar-shaped ovoids will be incorrect. They will be shown as 2.5 mm, while the Afterloader will deliver at 5.0 mm if the error is not detected during plan approval.
Affected products
Oncentra External Beam/Oncentra Brachy 4.5
Lot or serial number
Version 4.5
Version 4.5.1
Version 4.5.2
Model or catalog number
170.730
Companies
- Manufacturer
-
Nucletron B.V.
Waardgelder 1
Veenedaal
3905 TH
NETHERLANDS