RayStation and RayPlan (2018-01-26)
- Starting date:
- January 26, 2018
- Posting date:
- March 13, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-66120
Affected products
- RAYSTATION
- RAYPLAN
Reason
When more than one beam is defined on the same isocenter, Center Beam in Field (CBF) affects all beams in a way that the user may not expect. After using CBF, the resulting fields are clearly displayed in RayStation/RayPlan for review and approval. However, one mistreatment incident using the CBF functionality has been reported where the user failed to review the resulting beam apertures before treatment delivery.
Affected products
A. RAYSTATION
Lot or serial number
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
Model or catalog number
5
Companies
- Manufacturer
-
RaySearch Laboratories AB (PUBL)
Sveavagen 25
Stockholm
11134
SWEDEN
B. RAYPLAN
Lot or serial number
Not applicable
Model or catalog number
2
Companies
- Manufacturer
-
RaySearch Laboratories AB (PUBL)
Sveavagen 25
Stockholm
11134
SWEDEN