This page has been archived on the Web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.
RAYSTATION (2017-11-20)
- Starting date:
- November 20, 2017
- Posting date:
- November 30, 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, Hospitals, Healthcare Professionals
- Identification number:
- RA-65286
Affected products
RAYSTATION
Reason
This notice concerns an issue found with the electron dose calculation in RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (RayStation 6). When calculating electron Monte Carlo dose with a very large number of histories, the dose calculation may be wrong.
Affected products
RAYSTATION
Lot or serial number
RayStation 4.7.2.5
RayStation 5.0.2.35
Model or catalog number
4.0.3
5
6
Companies
- Manufacturer
-
RAYSEARCH LABORATORIES AB (PUBL)
SVEAVAGEN 44
STOCKHOLM
11134
SWEDEN