RAYSEARCH LABORATORIES AB: RayStation stand-alone software treatment planning system, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2), RayStation 7 (RayPlan 7) and RayStation 8A (RayPlan 8A) 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-2497-2018

Recalling firm

RAYSEARCH LABORATORIES AB

Product

RayStation stand-alone software treatment planning system, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2), RayStation 7 (RayPlan 7) and RayStation 8A (RayPlan 8A) 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

2018-06-29

Posted

not on file

Terminated

2020-07-16

Reason

If the beam model has a highly asymmetric primary source, it is not correctly taken into account in the calculation of DMLC fields when the collimator is rotated. This could lead to potentially significant overdosage at delivery. The user must be aware of the issue to avoid incorrect dose calculations during treatment planning.

Root cause

Under Investigation by firm

Action

On June 29, 2018, the firm issued an Urgent Field Safety Notice, Medical Device Correction #32484 to affected customers via email. The firm notified customers of the issue with the affected models: If the beam model has a highly asymmetric primary source, it is not correctly taken into account in the calculation of DMLC fields when the collimator is rotated. The user was instructed to do the following: 1. Inspect the beam model for all LINACs with jaw movement per beam, x-jaws and where the MLC is not above both jaws (i.e., Varian style LINACs) that allow DMLC planning. 2. If either the x- or y width of the primary source is below 0.01 cm or if they differ with more than a factor 2, do not use this beam model for DMLC. Contact RaySearch support for further assistance in adjusting the beam model and identifying potentially affected patients. 3. Please educate physics staff about this issue. 4. 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. The firm plans to resolve the issue in the next version of RayStation/RayPlan, scheduled for market release in 2018 (subject to market clearance in some markets).

Quantity

746

Distribution

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

Lot, serial or model codes

Software Versions 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 , 5.0.2.3 , 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 , 7.0.0.19 , 8.0.0.61

510(k) numbers

["K180379"]

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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