RAYSEARCH LABORATORIES AB: Medical Device Recall in 2026 - (Recall #: Z-1104-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Software Version: RayStation 11B, RayStation 11B SP1, RayStation 11B SP2, RayStation 11B SP3, RayStation 11B SPT1. Radiation Therapy Treatment Planning System

Product Classification:

Class II

Date Initiated: November 28, 2025

Date Posted: January 28, 2026

Recall Number: Z-1104-2026

Event ID: 98117

Reason for Recall:

Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.

Status: Ongoing

Product Quantity: 22 units

Code Information:

UDI: 0735000201042620211208, 0735000201049520220312, 0735000201050120220422, 0735000201060020220620 and 0735000201057020221222. GTIN: 07350002010426, 07350002010495, 07350002010501, 07350002010600 and 07350002010570. Serial Numbers: 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12, 12.3.0.119. Software Revisions: RayStation 11B, 11B SP1, 11B SP2, 11B SP3, 11B SPT1. Expiration Date: 2028-03-20.

Distribution Pattern:

Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS

Voluntary or Mandated:

Voluntary: Firm initiated