RAYSEARCH LABORATORIES AB: Medical Device Recall in 2023 - (Recall #: Z-1281-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: February 17, 2023

Date Posted: March 29, 2023

Recall Number: Z-1281-2023

Event ID: 91867

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.

Status: Ongoing

Product Quantity: 10770 systems

Code Information:

UDI-DI: 0735000201067920221007;

Distribution Pattern:

US Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated