Recall Z-1403-2022 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
RayStation 9B SP1. For radiation treatment planning.
| Date | Jun 1, 2022 |
| Status | Terminated |
| Reason | An issue with propagation of treatment course information from RayStation with RayTreat to RayCare has been identified. During some workflows, information may not be propagated to RayCare. |
| Root cause | Software change control |
| Action | The firm contacted all customers via email on June 1, 2022. Customers were provided with a list of workflows where safety related information may not be propagated. Customers were instructed to be aware that treatment course information in RayCare may not always be up to date. Customers should verify critical information in RayStation or RayTreat before treatment course information in RayCare is used for critical decisions. Customers were asked to identify all installed units with the affected software version numbers. The issue will be resolved in mandatory software updates for RayStation, |
| Quantity | 1 |
| Distribution | Worldwide distribution - US Nationwide distribution in the state of TN and the countries of Belgium and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200569 | RayStation RaySearch Laboratories AB (PUBL), Sep 24, 2020 |