Recall Z-1467-2020 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
RayStation/RayPlan 9A, Build Number 9.0.0.113, stand-alone software treatment planning system
| Date | Feb 20, 2020 |
| Status | Terminated |
| Reason | There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect. |
| Root cause | Under Investigation by firm |
| Action | An Urgent Field Safety Notice, Medical Device Correction notification letter dated 2/19/20 was emailed to the customer. ACTIONS TO BE TAKEN BY THE USER " Either do not use the RayTreat tabletop propagation functionality or make sure to always perform imaging and registration correction before each treatment session. " When using RayTreat in combination with the ProNova machine, do not use the acquired imaging positions in the preparation tab as the truth about where an image was actually taken. Please educate all users including the planning, Quality Assurance and plan delivery staff about th |
| Quantity | 1 system in the U.S. |
| Distribution | The products were distributed to the following US states: TN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190387 | RayStation RaySearch Laboratories AB (PUBL), Jun 19, 2019 |