Raystation treatment planning system for radiation therapy… recallZ-1281-2023 · Raysearch Laboratories AB · initiated Feb 17, 2023

Why it was recalled

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 category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number

Z-1281-2023

Recall class

Class II

Status

Open, Classified

Initiated by the company

Feb 17, 2023

Posted by the FDA

Mar 22, 2023

Recalling firm

Raysearch Laboratories AB

Quantity

10770 systems

Product code

MUJ

FDA submissions

K190387

Distribution

US Nationwide

Product description

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

Other devices under the same FDA submission

2 devices cleared under K190387 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• RayStation 9

  Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment
  12 recalls0 reports
• RayStation 8.1

  Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment
  8 recalls0 reports