Z-1838-2021Class II

RayStation (Treatment Planning System) Model Number RayStation is 6.0.0.24 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6...

Name: Z-1838-2021 RayStation (Treatment Planning System) Model Number RayStation is 6.0.0.24 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6...
Creator: Raysearch Laboratories Ab
Published: 2021-04-21
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2021-04-21 / Terminated

FDA source

RAYSEARCH LABORATORIES AB began a recall of 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... on 2021-04-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1838-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-21
Posted: 2021-06-09
Terminated: 2023-07-27
Recalling firm: RaySearch Laboratories AB (publ)
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 .
Product code: MUJ System, Planning, Radiation Therapy Treatment
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.
FDA 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 in commerce: 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,
Product codes and lots: Software version: RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 2 including some service packs.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1838-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1838-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-09

Product code MUJ

K200569Class IIRayStationRaySearch Laboratories AB (PUBL) / cleared 2020-09-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)