RayStation, RayPlan, and InverseArc 1.0 (2018-06-06)
- Starting date:
- June 6, 2018
- Posting date:
- June 22, 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-67084
Affected products
A. RayStation
B. InverseArc 1.0
C. RayPlan
Reason
When checking the dose distribution for an extreme off-axis field, it was noticed that the dose in the corners did not match that of the previously used planning system. When investigating the beam model, it was found that the beam profile corrections had inappropriate values outside the 20 cm radius.
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. InverseArc 1.0
Lot or serial number
4.3.0.14
Model or catalog number
4.3.0.14
Companies
- Manufacturer
-
RaySearch Laboratories AB (PUBL)
Sveavagen 25
Stockholm
11134
SWEDEN
C. RayPlan
Lot or serial number
- 6.0.0.24
- 6.1.0.26
- 6.1.1.2
- 6.2.0.7
- 7.0.0.19
Model or catalog number
- 2
- 7
Companies
- Manufacturer
-
RaySearch Laboratories AB (PUBL)
Sveavagen 25
Stockholm
11134
SWEDEN