Z-0866-2020Class II

RayStation stand-alone software treatment planning system. Models 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1...

Name: Z-0866-2020 RayStation stand-alone software treatment planning system. Models 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1...
Creator: Raysearch Laboratories Ab
Published: 2019-12-19
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2019-12-19 / Terminated / root cause: software

FDA source

RAYSEARCH LABORATORIES AB began a recall of RayStation stand-alone software treatment planning system. Models 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0 on 2019-12-19. FDA classified it as Class II and gives the reason as "Three issues found: i) The Map ROI options in the ROI list in the Structure Definition module may generate unintended ROI geometries ii) Elekta guard leaf behavior. There is an interoperability issue with Elekta...". 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-0866-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-19
Posted: 2020-01-27
Terminated: 2020-11-24
Recalling firm: RaySearch Laboratories AB (publ)
Product: RayStation stand-alone software treatment planning system. Models 4.0, 4.3, 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 code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Three issues found: i) The Map ROI options in the ROI list in the Structure Definition module may generate unintended ROI geometries ii) Elekta guard leaf behavior. There is an interoperability issue with Elekta regarding setting of guard leaves. iii)SSD, when intended as source-to-surface distance, it sometimes gives source-to-skin distance.To the best of our knowledge, these issues have not caused any patient mistreatment or other incidents. However, the user must be aware of the following information to avoid incorrect dose calculations during treatment planning.
Root cause tag: software
FDA root cause: Software design
Action: Field Safety Notice, Medical Device Correction #52889 #52672 #52971 dated 12/18/2019. ACTIONS TO BE TAKEN BY THE USER " i. Do not use the options Map ROI(s) or Map ROI(s) reversed, only available by right-clicking in the ROI list. Instead, use the Copy ROI geometries dialog available in the Structure Definition module or the Map ROIs dialog available in the Deformable Registration module. " ii. Be aware that the Elekta guard leaf setting from RayStation may be overridden by the R&V system or TCS. Contact the suppliers of your R&V system and TCS for more information. Scripting can be used to position the guard leaves according to the settings of the delivery system to avoid the overrides. " iii. Do not use the beam.GetSSD() scripting method. If needed in scripting, see RayCommunity. " iv. Do not use the SSD value displayed in the DRR in the plan report or exported DRR. Instead, use the SSD value displayed in the Beam data section of the plan report. Please educate planning staff and all users about these workarounds. Inspect your product and identify all installed units with the above software version number(s), then confirm you have read and understood this notice by replying to the notification email. SOLUTION i. The Map ROI issue will be resolved in a future version of RayStation, scheduled for market release in May 2020 (subject to market clearance in some markets). ii. The Elekta guard leaves issue will be resolved in a future version of RayStation, scheduled for market release in May 2020 (subject to market clearance in some markets). iii. The SSD issue will be resolved in the next version of RayStation, scheduled for market release in December 2019 (subject to market clearance in some markets). If customers wish to continue using versions of RayStation 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.
Quantity in commerce: 3114 Devices/Licenses
Distribution: US Nationwide distribution in 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, NV, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, VT, WA, WI
Product codes and lots: Software Versions Numbers: 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 , 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 , 9.0.0.113 .

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0866-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0866-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-02-04

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)