Recall Z-0478-2021 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
RayStation standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1, 9.2, 10.0 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may
| Date | Oct 8, 2020 |
| Status | Terminated |
| Reason | If a region of interest (ROI) or point of interest (POI) that is referenced from an imported plan is missing in the imported RT Structure Set, the reference may become linked to the wrong ROI or POI. |
| Root cause | Software design |
| Action | On October 8, 2020, the firm emailed "Field Safety Notice, Medical Device Correction #66704" to affected customers. Customers were made aware of the product issue and asked to take the following actions: " Do not exclude the prescription ROI or POI when exporting from RayStation with the Exclude from export option. " If an RT Structure Set where it is not certain that all referenced bolus and prescription ROIs or POIs are present is imported to RayStation, make sure to check that any intended references to bolus and prescription are correct after import. " Please educate planning staff and a |
| Quantity | 2768 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200569 | RayStation RaySearch Laboratories AB (PUBL), Sep 24, 2020 |