Z-1194-2025Class II

Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number...

Name: Z-1194-2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number...
Creator: Raysearch Laboratories Ab
Published: 2025-01-16
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2025-01-16 / Open, Classified / root cause: manufacturing process

FDA source

RAYSEARCH LABORATORIES AB began a recall of Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 5.0.2.35 and 5.0.3.17 Software Version: RayStation 5... on 2025-01-16. FDA classified it as Class II and gives the reason as "Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1194-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-16
Posted: 2025-02-19
Recalling firm: RaySearch Laboratories AB (publ)
Product: Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 5.0.2.35 and 5.0.3.17 Software Version: RayStation 5 Service Pack 2 and 3
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Raysearch issued Field Safety Notice, Medical Device Correction #148655 RayStation version 4.5 to 2024B including some service packs via email on 1/17/25. Letter states reason for recall, health risk and action to take: For users of HU-to-mass density CT calibration curves If a user wants to evaluate a plan with respect to relative stopping power/WE range error rather than mass density errors, there are two options: Option 1. Use a HU-to-SPR CT calibration curve instead of a HU-to-mass density curve. " For evaluation of an existing case, the evaluation can be done on an anonymized and exported copy of the patient and plan. " Contact RaySearch Service if you need help with the creation of a HU-to-SPR curve from an existing HU-to-mass density curve. Option 2. Evaluate the plan using a higher (effective) mass density uncertainty that gives similar relative stopping power and WE range change as the nominal value. " The following values of Effective mass density errors that give similar result as an intended Stopping power error have been deduced from a limited set of patients: " For other values of intended Stopping power error, interpolate the approximate Effective mass density value from the table above. " The values are estimates based on a few patients and are expected to vary slightly depending on the mass densities along the beam path. " Note that the values are not symmetrical around 0. For users of HU-to-SPR CT calibration curves Be aware that the density uncertainty given in Robust evaluation, Compute perturbed dose and Robust optimization is used directly to scale stopping power and therefore WE range. Starting from RayStation v2025, scheduled for market release in April 2025 (subject to market clearance in some markets), the impact of the mass density uncertainty in Robust evaluation and Compute perturbed dose when using a HU-to-mass density CT calibration curve will be changed to harmonize with the other use cases. This means that as of RayStat
Quantity in commerce: 0
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Belgium ENG, Canada, China, China APactron, Denmark, France, Germany, Hong Kong S.A.R. China, India, Italy, Japan, Korea, Netherlands, Norway, Poland, Singapore, Spain, SwitzerlandENG, Taiwan, Thailand, UK.
Product codes and lots: Lot Code: UDI: 0735000201002020170502 GTIN: 07350002010020 Serial Numbers: 5.0.2.35 and 5.0.3.17 Software Revisions: RayStation 5 Service Pack 2 and 3 Expiration Date: 2028-12-21

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1194-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1185-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-19
Z-1186-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-19
Z-1187-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-19
Z-1188-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-19
Z-1189-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-19
Z-1190-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-19
Z-1191-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-19
Z-1192-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-19
Z-1193-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-19
Z-1194-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-19
Z-1195-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-19

Product code MUJ

K160093Class IIRayStationRaySearch Laboratories AB (PUBL) / cleared 2016-04-08

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)