Z-1104-2026Class II

RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Software Version...

Name: Z-1104-2026 RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Software Version...
Creator: Raysearch Laboratories Ab
Published: 2025-11-28
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2025-11-28 / Open, Classified

FDA source

RAYSEARCH LABORATORIES AB began a recall of 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... on 2025-11-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1104-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-28
Posted: 2026-01-16
Recalling firm: RaySearch Laboratories AB (publ)
Product: 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 code: MUJ System, Planning, Radiation Therapy Treatment
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.
FDA root cause: Under Investigation by firm
Action: RaySearch Laboratories notified consignees via email on about 12/05/2025. Consignees were instructed to follow the outlined steps in the notification letter when adding geometry to an empty ROI with MO or type Bolus, Fixation or Support, educate planning staff and all users about the workaround, inspect units and identify all installed units with the affected software version numbers, and confirm receipt and understanding of the customer notification by responding to the notification email. The issue will be resolved in the next version of RayStation, scheduled for market release in December 2025 (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. The upgrade to an unaffected software version will be scheduled in coordination with the authorized personnel, considering the specific circumstances and requirements of each individual case. The upgrade may be conducted remotely or onsite, as deemed appropriate.
Quantity in commerce: 22 units
Distribution: Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1104-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1102-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-28	2026-01-16
Z-1103-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-28	2026-01-16
Z-1104-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-28	2026-01-16
Z-1105-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-28	2026-01-16
Z-1106-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-28	2026-01-16
Z-1107-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-28	2026-01-16
Z-1108-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-28	2026-01-16
Z-1109-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-28	2026-01-16
Z-1110-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-28	2026-01-16

Product code MUJ

K220141Class IIRayStation 11BRaySearch Laboratories AB (PUBL) / cleared 2022-04-15

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)