Z-2290-2018Class II

RayStation Radiation Therapy Treatment Planning System; 6.0, 6.1, 6.2, 7.0

Name: Z-2290-2018 RayStation Radiation Therapy Treatment Planning System; 6.0, 6.1, 6.2, 7.0
Creator: Raysearch Laboratories Ab
Published: 2018-03-28
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2018-03-28 / Terminated / root cause: software

FDA source

RAYSEARCH LABORATORIES AB began a recall of RayStation Radiation Therapy Treatment Planning System; 6.0, 6.1, 6.2, 7.0 Product Usage: Usage: RayStation is a software system designed for treatment... on 2018-03-28. FDA classified it as Class II and gives the reason as "The dose calculation accuracy may in some situations be less than expected. The user must be aware in order to avoid incorrect dose calculations during treatment planning". 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-2290-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-28
Posted: 2018-06-26
Terminated: 2020-05-27
Recalling firm: RaySearch Laboratories AB (publ)
Product: RayStation Radiation Therapy Treatment Planning System; 6.0, 6.1, 6.2, 7.0 Product Usage: 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: The dose calculation accuracy may in some situations be less than expected. The user must be aware in order to avoid incorrect dose calculations during treatment planning.
Root cause tag: software
FDA root cause: Software design
Action: On March 28, 2018, the firm issued a Field Safety Notice, Medical Device Correction letter to its affected customers. The firm instructed users to take the following actions: -Do not use MLC only collimated to set output factor corrections (OFCs) in beam modeling of Elekta Synergy machines with MLCi/MLCi2 or any other machine with the MLC closer to the source than both the x- and y-jaws. Always use Jaws and MLC collimated. -Be aware that there is an error in the field measure calculation for machines with the MLC closer to the source than both the x- and y-jaws, and for machines with fixed jaws. Make sure to perform patient-specific QA before treatment delivery for treatment plans with fields where: 1) closed MLC leaves are positioned inside the jaw field and 2) the minimum static/dynamic tip gap is larger than 0.001 cm. 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 you have read and understood this information by replying to the notification email. This issue will be resolved in the next version of RayStation/RayPlan, scheduled for market release in June 2018 (subject to market clearance in some markets). If customers wish to continue using versions of RayStation/RayPlan affected by this Field Safety Notice, all users must maintain awareness of this Field Safety Notice. Alternatively, customers can choose to upgrade to the new version once it becomes available for clinical use.
Quantity in commerce: 728
Distribution: US Nationwide Distribution in the states of AL, AR, AZ, CA, CT, DC, DE, FL, GA, HI, ID, IL, MA, MD, ME, MI, MO, MS, MT, NC, NJ, NY, OH, OR, PA, TN, TX, UT, VA, VT, WA, WI.
Product codes and lots: 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 and 7.0.0.19

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2290-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2290-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-26

Product code MUJ

K171536Class IIRayStationRaySearch Laboratories AB (PUBL) / cleared 2017-06-27

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)