RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatme
Summary
The FDA issued a Class II for RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/R by RAYSEARCH LABORATORIES AB. Reason: Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for s.
Details
Source
Device Recall
External ID
Z-1102-2026
Action Date
2026-01-28
Status
Ongoing
Category
device
Product Description
RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatment Planning System
Lot/Code Info: UDI: 0735000201031020201216. GTIN: 07350002010310. Serial Numbers: 10.1.0.613. Software Revision: RayStation 10B. Expiration Date: 2027-02-01.
Quantity Affected: 0
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.
Distribution
Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS
Type: Voluntary: Firm initiated
Recall Initiated: 2025-11-28
Company
Stockholm
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 180 device recalls issued in the same week, part of 403 device-related FDA actions this month.
RAYSEARCH LABORATORIES AB has 51 FDA actions in our database, including 51 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (RAYSEARCH LABORATORIES AB) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does RAYSEARCH LABORATORIES AB have FDA actions?
RAYSEARCH LABORATORIES AB has 51 FDA actions in our database, including 51 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1102-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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