Recall Z-1317-2012 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
RayStation Version 2.0.0.15, Radiation Therapy Treatment Planning System. RaySearch Laboratories AB Sveavagen 25, SE-111 34 Stockholm Sweden. support@raysearchlabs.com Designed for treatment planning and analysis of radiation therapy.
| Date | Mar 26, 2012 (initiated Dec 6, 2011) |
| Status | Terminated |
| Reason | An issue was found with the dose calculation in the RayStation 2.0, that could result in a potential overestimation of the dose. This could lead to the potential under-dosage of a patient. |
| Root cause | Device Design |
| Action | The firm decided to recall and sent Urgent Field Safety Notice Medical Device Correction letters to consignees on 12/06/2011. The letters described the issue, identified the affected product, actions to be taken by the user, a solution, and contact information. Users are to follow the two part workaround, and educate their staff and all users on the workarounds. The letter states that the issue will be resolved in the next version of RayStation. If further information is needed, users are to contact either Freddie Cardel, Director of Customer Support, RaySearch Americas, at 1-877-778-3849 |
| Quantity | 21 units (16 domestically and 5 internationally) |
| Distribution | Worldwide Distribution -- US, including the states of FL, MA, NJ, and NY and the country of the Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100552 | RAYSTATION VERSION 1.0 Raysearch Laboratories AB, Mar 12, 2010 |