RayStation and RayPlan (2018-06-29)
- Starting date:
- June 29, 2018
- Posting date:
- July 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-67278
Affected products
A. RayStation
B. RayPlan
Reason
This recall concerns an issue found with the dynamic MultiLeaf Collimator (dMLC ) "sliding window" photon dose calculation in RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2), RayStation 7 (RayPlan 7) and RayStation 8a (RayPlan 8a) for machines with jaw movement per beam, x-jaws and where the MLC is not above both jaws (i.e., varian style linacs). If the beam model has a highly asymmetric primary source, it is not correctly taken into account in the calculation of dMLC fields when the collimator is rotated.
Affected products
A. RayStation
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
4.0.3
5
6
7
Companies
- Manufacturer
-
RaySearch Laboratories AB (PUBL)
Sveavagen 25
Stockholm
11134
SWEDEN
B. RayPlan
Lot or serial number
7.0.0.19
8.0.0.61
Model or catalog number
2
7
Companies
- Manufacturer
-
RaySearch Laboratories AB (PUBL)
Sveavagen 25
Stockholm
11134
SWEDEN