RAYSEARCH LABORATORIES AB: RayStation stand-alone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0 - Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.

Recall number

Z-0736-2020

Recalling firm

RAYSEARCH LABORATORIES AB

Product

RayStation stand-alone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0 - Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.

Status

Terminated

Initiated

2019-11-18

Posted

not on file

Terminated

2020-11-10

Reason

Editing a static arc beam may unexpectedly set the MU of the beam to its initial default value of 200 MU. If the bug is triggered, the dose is invalidated and needs to be recalculated before the plan can be approved or exported.

Root cause

Software design

Action

Field Safety Notice, Medical Device Correction notification letters dated 11/18/19 were sent to customers. ACTIONS TO BE TAKEN BY THE USER " Be aware that the MU of static arc beams may change unexpectedly when using the Edit beam dialog or when editing the beam aperture. " Always review the final dose before approving a plan for treatment: WARNING! Plan review and approval. All treatment plan data shall be carefully reviewed and approved by a qualified person before it is used for radiotherapy treatment purposes. A plan (beam set) that is 'optimal' with respect to the optimization goals may still be inappropriate for clinical use. (508826, 508814) Please educate planning staff and all users about this workaround. Inspect your product and identify all installed units with the above software version number(s), then confirm that you have read and understood this notice by replying to the notification email. SOLUTION This issue will be resolved in the next version of RayStation/RayPlan, scheduled for market release in December 2019 (subject to market clearance in some markets). If customers wish to continue using versions of RayStation/RayPlan affected by this notice, all users must maintain awareness of this notice. Alternatively, customers can choose to upgrade to the new version once it becomes available for clinical use. TRANSMISSION OF THIS NOTICE This notice needs to be passed on to all those who need to be aware within your organization. Please maintain awareness of this notice as long as any version of RayStation/RayPlan affected by this issue is in use to ensure effectiveness of the workaround.

Quantity

956 Devices/Licences

Distribution

US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, LA, MA, MD, ME, MI, MO, MS, MT, NC, NJ, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, VT, WA, and WI.

Lot, serial or model codes

Software Version Numbers: 4.0.0.14 , 4.0.1.4 , 4.0.2.9 , 4.0.3.4 , 4.5.0.19 ,  4.5.1.14 , 4.5.2.7 , 4.7.0.15 , 4.7.1.10 , 4.7.2.5 , 4.7.3.13 , 4.7.4.4 , 4.7.5.4 , 4.9.0.42 , 5.0.0.37 ,  5.0.1.11 5.0.2.35 , 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.61 , 8.0.1.10 ,  8.1.0.47 , 8.1.1.8 , 8.1.2.5 , or 9.0.0.113

510(k) numbers

["K190387"]

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

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