This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
ONCENTRA EXTERNAL BEAM/ONCENTRA BRACHY 4.5 (2015-12-18)
- Starting date:
- December 18, 2015
- Posting date:
- January 18, 2016
- 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-56678
Affected Products
A. ONCENTRA EXTERNAL BEAM/ONCENTRA BRACHY 4.5
Reason
When using the option "Tumor Overlap Fraction" in VMAT planning it has been observed that in rare cases the system does include an organ at risk as target volume. This could result in open MLC, and open jaws in areas away from the target volume.
Affected products
A. ONCENTRA EXTERNAL BEAM/ONCENTRA BRACHY 4.5
Lot or serial number
19311-EB001
Model or catalog number
170.730
Companies
- Manufacturer
-
Nucletron B.V.
Waardgelder 1
Veenedaal
3905 TH
NETHERLANDS