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Brand Name: RayStation- Intended as a Radiation Therapy… recallZ-1189-2025 · Raysearch Laboratories AB · initiated Jan 16, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Raysearch Laboratories AB or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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

Recall details

Recall number
Z-1189-2025
Status
Open, Classified
Initiated by the company
Jan 16, 2025
Posted by the FDA
Feb 19, 2025
Recalling firm
Raysearch Laboratories AB
Quantity
6
Product code
MUJ
FDA submissions
K211867
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 description

Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 1.0.0.951, 11.0.1.29, 11.0.3.116 and 11.0.4.15 Software Revisions: RayStation 11A and 11A Service Pack 1, 2 and 3

Code information (models, lots, serial numbers)

Lot Code: UDI: 0735000201038920210518, 0735000201043320210610, 0735000201044020210916 and 0735000201063120220616 GTIN: 07350002010389, 07350002010433, 07350002010440 and 07350002010631 Serial Numbers: 11.0.0.951, 11.0.1.29, 11.0.3.116 and 11.0.4.15 Software Revisions: RayStation 11A and 11A Service Pack 1, 2 and 3 Expiration Date: 2027-06-22

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 96156).

Sources and updates

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