Recall Z-1427-2021 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B (10.1.0.613)
| Date | Mar 25, 2021 |
| Status | Open, Classified |
| Reason | Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat. |
| Root cause | Under Investigation by firm |
| Action | On 03/25/2021, RaySearch Laboratories issued an Urgent Medical Device Correction notice via email to their customer notifying them of an issue found with the display of flags in RayTreat. Flags edited in RayCare after a patient has been checked in, may not be updated in RayTreat. |
| Quantity | 1 system |
| Distribution | US Nationwide in the state of TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200569 | RayStation RaySearch Laboratories AB (PUBL), Sep 24, 2020 |