RayStation (2018-09-18)
- Starting date:
- September 18, 2018
- Posting date:
- October 19, 2018
- 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-68044
Affected products
RayStation
Reason
Issue found with robust optimization in Raystation 4.5, Raystation 4.7, Raystation 5, Raystation 6 and Raystation 7. When using robust optimization functions the background dose is not taken into account, although in some cases it is displayed as such in the user interface. The user must be aware of this information to avoid creating treatment plans that are less robust than intended.
Affected products
RayStation
Lot or serial number
RayStation 4.5.0.19
RayStation 4.5.1.14
RayStation 4.5.2.7
RayStation 4.7.0.15
RayStation 4.7.1.10
RayStation 4.7.2.5
RayStation 4.7.3.13
RayStation 4.7.4.4
RayStation 4.7.5.4
RayStation 5.0.0.37
RayStation 5.0.1.11
RayStation 5.0.2.35
RayStation 6.0.0.24
RayStation 6.1.0.26
RayStation 6.1.1.2
RayStation 6.2.0.7
RayStation 7.0.0.19
Model or catalog number
4.5
4.7
5
6
7
Companies
- Manufacturer
-
RaySearch Laboratories AB (PUBL)
Sveavagen 25
Stockholm
11134
SWEDEN