Recall Z-1597-2021 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A, 10A, 10B including some of the Service Packs. Standalone software treatment planning system
| Date | Feb 22, 2021 |
| Status | Terminated |
| Reason | For some LINAC types, merging clinical beams with beams of approximate dose may lead to the approximate dose erroneously labeled as clinical dose. Merge beams can be used manually, in scripting, or as part of the Automated breast planning feature. In some cases, when merging two beams where the first beam has clinical dose and the second beam has approximate dose, the dose of the resulting beam will be labeled as Clinical, although dose for some of the beam segments is still calculated with the SVD dose engine and it should be labeled Approximate: Mixed dose. The difference between approximate |
| Root cause | Software design |
| Action | RaySearch issued Field Safety Notice, Medical Device Correction #74977 letter on 22 February 2021 via Email. Letter states reason for recall, health risk and action to take: ACTIONS TO BE TAKEN BY THE USER " Manual Merge beams in the 3D-CRT module Scenario: When merging a beam B1 with other beams (e.g., B2 and B3) in the 3D-CRT module. Action: If the target beam B1 has a clinical dose before the merge, make sure that all the beamsto be merged (B2 and B3) also have a clinical dose computed with the same dose engine. " Scripting when using the action MergeBeamSegments Scenario: When running a sc |
| Quantity | 116 units |
| 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 |