RAYSEARCH LABORATORIES AB: RayStation Radiation Therapy Treatment Planning System, Model nos. 2.5, 3.5, 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 7.0 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-2554-2018

Recalling firm

RAYSEARCH LABORATORIES AB

Product

RayStation Radiation Therapy Treatment Planning System, Model nos. 2.5, 3.5, 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 7.0 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

2018-06-06

Posted

not on file

Terminated

2019-04-04

Reason

The firm has learned that some RayStation/RayPlan users have commissioned machines with erroneous Beam profile correction parameters. These parameters affect the dose calculated in corners of large or off-axis fields. This effect cannot be seen in the Beam Commissioning module and dose in large or off-axis fields needs to be validated using the Beam 3D Modeling module in RayPhysics/RayPlan Physics. The user must be aware to avoid incorrect dose calculations during treatment planning.

Root cause

Software design

Action

On June 6, 2018, the firm issued an Urgent Field Safety Notice, Medical Device Correction letter to affected customers via email. The notice was a reminder to follow the instructions listed in the product documentation when creating a photon beam model in RayStation/RayPlan. ACTIONS TO BE TAKEN BY THE USER " Always validate the beam model for all clinically relevant fields, including, but not limited to, large and off-axis fields, before the system is used to create clinical treatment plans. " Carefully review all beam model parameters before commissioning. " Be aware that the Beam profile correction values may need to be adjusted in order to correctly model the primary collimator that limits the dose in the corners of large or off-axis fields. " Review any existing photon beam models to ensure that the actions above have been properly performed. Please educate physics staff about these user responsibilities. 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. Safe use relies on careful validation of the beam model for all clinically relevant fields before the system is used to create clinical treatment plans. This information is already present in the Instructions For Use, the Reference Manual and the RayPhysics/RayPlan Physics Manual for the existing product versions. To further reduce the risk of using improper beam models, the safety warnings within the product documentation will be updated in the next version of RayStation/RayPlan, scheduled for market release in June 2018.

Quantity

718

Distribution

US Nationwide distribution.

Lot, serial or model codes

2.5.1.89 , 3.5.0.16 , 3.5.1.6 , 4.0.0.14 , 4.0.1.4 4.0.2.9 , 4.0.3.4 , 4.3.0.14 , 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 , 7.0.0.19 .

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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