RayStation (2020-03-04)
- Starting date:
- March 4, 2020
- Posting date:
- April 16, 2020
- 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-72743
Last updated: 2020-04-16
Affected Products
RayStation
Reason
Due to physical limitations of the treatment machine, the maximum field opening for Siemens virtual wedge fields recommended by the linac vendor will be more restricted in the wedged direction than the maximum field opening without a wedge. Delivering a larger field opening with a virtual wedge will not result in a wedged field shape over the entire field. Instead, a high dose plateau region will be the result at the toe side of the field beyond the recommended field size.
Affected products
RayStation
Lot or serial number
- Version 4.5.0.19
- Version 4.5.1.14
- Version 4.5.2.7
- Version 4.7.2.5
- Version 5.0.2.35
- Version 6.1.1.2
- Version 7.0.0.19
Model or catalog number
- RAYSTATION 4.5
- RAYSTATION 4.7
- RAYSTATION 5
- RAYSTATION 6
- RAYSTATION 7
Companies
- Manufacturer
-
RaySearch Laboratories AB (PUBL)
Sveavagen 25
Stockholm
11134
SWEDEN