Z-0736-2020Class II

RayStation stand-alone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1...

Name: Z-0736-2020 RayStation stand-alone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1...
Creator: Raysearch Laboratories Ab
Published: 2019-11-18
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2019-11-18 / Terminated / root cause: software

FDA source

RAYSEARCH LABORATORIES AB began a recall of 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... on 2019-11-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0736-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-18
Posted: 2019-12-23
Terminated: 2020-11-10
Recalling firm: RaySearch Laboratories AB (publ)
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.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: 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 tag: software
FDA 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 in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0736-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0736-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-01	2019-12-23

Product code MUJ

K190387Class IIRayStationRaySearch Laboratories AB (PUBL) / cleared 2019-06-19

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)