Recall Z-2426-2020 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9.0, 9.1, 9.2
| Date | May 26, 2020 |
| Status | Open, Classified |
| Reason | It is not obvious that the manual import of a treatment record into RayCare PACS does not automatically import the same data into RayTreat. In addition, there is an issue found with the display of planned and recorded Gantry Angle in the delivered beam list in RayTreat. |
| Root cause | Under Investigation by firm |
| Action | On May 26, 2020, the firm notified affected customers of the product issue via emailed Field Safety Notices. Customers were made aware of the following issues: 1) When only a single beam record is received for a specific beam, the delivered Gantry angle is hidden and only the planned Gantry angle is shown, and 2) For users of RayCare 3B and RayStation RayTreat 9B (including all service packs), if a manual import is necessary, the treatment record must be imported manually into both RayStation and PACS. ACTIONS TO BE TAKEN BY THE USER " Be aware that the Gantry angle column in the first row fo |
| Quantity | 12 |
| Distribution | Distributed to one consignee in Nashville. Foreign distribution to one consignee in Belgium. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190387 | RayStation RaySearch Laboratories AB (PUBL), Jun 19, 2019 |