RAYSEARCH LABORATORIES AB: 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 .

Recall number

Z-1838-2021

Recalling firm

RAYSEARCH LABORATORIES AB

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 .

Status

Terminated

Initiated

2021-04-21

Posted

not on file

Terminated

2023-07-27

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.

Root cause

Under Investigation by firm

Action

On May 6, 2021, Raysearch issued an Urgent Medical Device Correction notice to customers via letter notifying them an issue was found with the voxelwise worst clinical goals in the Robust evaluation module for specified software versions of RayStation. Evaluation of a clinical goal for the voxelwise worst dose distributions may be misleading after editing the clinical goal. Actions to be taken by the user Voxelwise worst clinical goal in Robust evaluation - The user is advised to be careful when editing clinical goals in the Robust evaluation module and when evaluating the clinical goals for the voxelwise worst distributions. If a clinical goal needs to be edited, make sure to toggle between the Scenario view and Voxelwise min and max views to trigger an update. Contouring issue - The user is advised to always examine ROI geometries in the transversal view and in the reconstructed sagittal, coronal and 3D views to verify that they have the desired size and shape. - To avoid displaying a mix of manually drawn and reconstructed contours in the same 2D view, the user can explicitly convert the ROI geometry to voxel- or mesh representation by using the keep component tool or the deformation tool. This way all rendered contours will be reconstructed and also be identical to what will be exported. All - Educate planning staff and all users about these issues and the workarounds. - Inspect your product and identify all installed units with the above software version number(s). - Confirm you have read and understood this notice by replying to the notification email. Solution The voxelwise worst issue will be resolved in the next version of RayStation, scheduled for market release in May 2021 (subject to market clearance in some markets). The contouring issue was resolved in RayStation 10B. If customers wish to continue using versions of RayStation affected by this notice, all users must maintain awareness of this notice. Alternatively, customers ca

Quantity

Domestic: 13,722 systems

Distribution

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AZ, CA, CT, DC, DE, FL, GA, HI, ID, IL, LA, MA, MD, ME, MI, MO, MS, MT, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Canada, Colombia, Czech Republic, Denmark, Egypt, Estonia, France, French Polynesia, Germany, Hong Kong, China, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK,

Lot, serial or model codes

Software version: RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 2 including some service packs.

510(k) numbers

["K200569"]

PMA numbers

not on file

Product code

MUJ

Firm FEI

3007774465

Firm city

Stockholm

Firm state

not on file

Firm country

Sweden

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy