Z-2497-2018Class II

RayStation stand-alone software treatment planning system, RayStation 4.5, RayStation 4.7, RayStation 4.9...

Name: Z-2497-2018 RayStation stand-alone software treatment planning system, RayStation 4.5, RayStation 4.7, RayStation 4.9...
Creator: Raysearch Laboratories Ab
Published: 2018-06-29
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2018-06-29 / Terminated

FDA source

RAYSEARCH LABORATORIES AB began a recall of RayStation stand-alone software treatment planning system, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2)... on 2018-06-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2497-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-29
Posted: 2018-07-19
Terminated: 2020-07-16
Recalling firm: RaySearch Laboratories AB (publ)
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.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: 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.
FDA 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 in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2497-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2497-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-19

Product code MUJ

K180379Class IIRayStation 7RaySearch Laboratories AB (PUBL) / cleared 2018-04-25

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)