Recall Z-2138-2021 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
RayStation (Radiation Treatment Planning System) : RayStation 9A, 9B, 9B SP1, 10A, 10A SP1, 10B and 11A, in combination with RayCare Model Numbers/ UDI: RayStation 9.0 (9.0.0.113) 07350002010174; RayStation 9.1 (9.1.0.933) 07350002010266; RayStation 9.1 Service Pack 1 (9.2.0.483) 07350002010297; RayStation 10.0 (10.0.0.1154) 07350002010303; RayStation 10.0 Service Pack 1 (10.0.1.52) 0735000201
| Date | Jun 8, 2021 |
| Status | Terminated |
| Reason | Initial delivery positions will be set incorrectly when having setup beam(s) at the localization point. |
| Root cause | Under Investigation by firm |
| Action | RaySearch issued Urgent Field Safety Notice, Medical Device Correction #80230 via email on 06/08/21. Letter states reason for recall, health risk and action to take: TO BE TAKEN BY THE USER " Do not create setup beams with the localization point as isocenter (option 2). " Always perform secondary verification of new treatment positions. RayTreat will notify the user when the treatment positions have been updated. " Always perform imaging before treating the patient. " Educate planning staff and all users about this workaround. " Inspect your product and identify all installed units with the a |
| Quantity | 5 units |
| Distribution | US distribution to TN; and Belgium |
| FDA record | Open on fda.gov |