RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant.

Recommended Action

Per FDA guidance

On February 26, 2024, the firm notified customers of the issue via Urgent Field Safety Notice: Medical Device Correction letters via email. Actions to be taken by the user: 1. Educate planning staff and all users about the possibility of the described use error. 2. If the use error is deemed likely to occur at your clinic, take actions to ensure that proper review of assigned materials is performed before a patient model is used for treatment planning. 3. If you wish to have the Silicon chemical element removed from the material list, contact RaySearch support for assistance. This is especially recommended for clinics that perform ion beam treatments, where the harm caused by the use error could be significant. 4. Inspect your product and identify all installed units with the above software version number(s). 5. Confirm you have read and understood this notice by replying to the notification email. The Silicon chemical element will not be included in the next version of RayStation/RayPlan, scheduled for market release in April 2024 (subject to market clearance in some markets). If requested by the customer, it can be removed from the material list of existing installations. 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. Thank you for your cooperation, and we apologize for any inconvenience. For regulatory information, please contact quality@raysearchlabs.com.