Z-1281-2023Class II

Raystation treatment planning system for radiation therapy, Model Numbers 9.0.0, 9.0.1, 9.1.0, 9.2.0, 10.0.0...

Name: Z-1281-2023 Raystation treatment planning system for radiation therapy, Model Numbers 9.0.0, 9.0.1, 9.1.0, 9.2.0, 10.0.0...
Creator: Raysearch Laboratories Ab
Published: 2023-02-17
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2023-02-17 / Open, Classified

FDA source

RAYSEARCH LABORATORIES AB began a recall of Raystation treatment planning system for radiation therapy, Model Numbers 9.0.0, 9.0.1, 9.1.0, 9.2.0, 10.0.0, 10.0.1, 10.0.2, 10.1.0, 10.1.1, 11.0.0, 11.0.1... on 2023-02-17. FDA classified it as Class II and gives the reason as "It is possible to set a non-zero collimator angle in the Virtual Simulation module. The angle will be correct in the user interface but if the plan is DICOM exported by using the VSIM Export button, the angle will not...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1281-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-17
Posted: 2023-03-22
Recalling firm: RaySearch Laboratories AB (publ)
Product: Raystation treatment planning system for radiation therapy, Model Numbers 9.0.0, 9.0.1, 9.1.0, 9.2.0, 10.0.0, 10.0.1, 10.0.2, 10.1.0, 10.1.1, 11.0.0, 11.0.1, 11.0.3, 11.0.4, 12.0.0, 12.1.0, 12.1.1, 12.0.3, 12.1.2, 12.0.4, 12.1.3, 13.0.0, 13.1.0. Software Version Numbers 9A, 9B, 10A, 10B, 11A, 11B and 12A including service packs
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: It is possible to set a non-zero collimator angle in the Virtual Simulation module. The angle will be correct in the user interface but if the plan is DICOM exported by using the VSIM Export button, the angle will not be correct in the exported RT plan. In the exported RT plan, the DICOM attribute Beam Limiting Device Angle (300A,0120) is set to zero, regardless of the selected collimator angle.
FDA root cause: Under Investigation by firm
Action: A Field Safety Notice, Medical Device Correction letter dated 2/16/23 was sent to customers. Actions to be taken by the user " Be aware that an RT plan exported by using the VSIM Export button will always have the DICOM attribute Beam Limiting Device Angle (300A,0120) set to zero. " Be aware that an RT plan exported by using the VSIM Export button will always have the DICOM attribute Number of Wedges (300A,00D0) set to zero and no wedge information will be exported. " Be aware that an RT plan exported by using the VSIM Export button will never include the DICOM attribute Applicator Sequence (300A,0107) and no cone information will be exported. " Do not use or export Virtual Simulation plans with non-zero collimator angle, wedges or cones using the VSIM Export button. " Be aware that a plan imported as a Virtual Simulation plan may not contain all intended information and that some attributes affecting dose may be different from the original plan. " Always perform dose computation for imported Virtual Simulation plans before export. Do not use the VSIM Export for export of such plans. " Educate planning staff and all users about this workaround. " Inspect your product and identify all installed units with the above software version number(s). " Confirm 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, scheduled for market release in June 2023 (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. Transmission of this Notice This notice needs to be passed on to all those who need to be aware within your organization. Maintain awareness of this notice as long as any affected version is in use.
Quantity in commerce: 10770 systems
Distribution: US Nationwide
Product codes and lots: UDI-DI: 0735000201067920221007;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1281-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1281-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-29	2023-03-22

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)