Recall Z-1838-2021— RAYSEARCH LABORATORIES AB

Name: FDA recall Z-1838-2021
Creator: U.S. Food and Drug Administration
Published: 2021-04-21

Class II · Terminated

Class II FDA medical device recall by RAYSEARCH LABORATORIES AB, initiated 2021-04-21, terminated 2023-07-27. It names one FDA 510(k) clearance: K200569. Product: RayStation (Treatment Planning System) Model Number RayStation is 6.0.0.24 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.6 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 , 10.0.0.1154 , 10.0.1.52 or 10.1.0.613 .. Reason: Evaluation of a clinical goal for the voxelwise worst dose distributions may be misleading after editing the clinical goal. It also describes an issue with contouring when the spacing between slices is d 1 mm, present in RayStation/RayPlan versions from 6 up to 10A..

Recalling firm: RAYSEARCH LABORATORIES AB
Classification: Class II
Status: Terminated
Initiated: 2021-04-21
Terminated: 2023-07-27
Firm location: Stockholm, N/A, Sweden

510(k) clearances named in this recall

1 on FDA's record

K200569 — RayStationRaySearch Laboratories AB (PUBL)·cleared 2020-09-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

RayStation (Treatment Planning System) Model Number RayStation is 6.0.0.24 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.6 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 , 10.0.0.1154 , 10.0.1.52 or 10.1.0.613 .

Reason for recall

Evaluation of a clinical goal for the voxelwise worst dose distributions may be misleading after editing the clinical goal. It also describes an issue with contouring when the spacing between slices is d 1 mm, present in RayStation/RayPlan versions from 6 up to 10A.

Data sourced from openFDA. This site is unofficial and independent of the FDA.