Recall Z-1679-2015 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the i
| Date | May 27, 2015 (initiated May 8, 2015) |
| Status | Terminated |
| Reason | RaySearch Laboratories AB became aware of an issue with the dose calculation for some imported VMAT plans where controls points are defined with wide gantry angle spacing. |
| Root cause | Software Design Change |
| Action | RaySearch sent a Device Correction letter dated May 8, 2015 via e-mailed to their customers. The letter identified the affected product, problem, actions to be taken by users and contact information. |
| Quantity | Domestic: 539 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |