Z-1191-2025Class II
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number...
RaySearch Laboratories AB (publ) / initiated 2025-01-16 / Open, Classified / root cause: manufacturing process
RAYSEARCH LABORATORIES AB began a recall of Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 and 14.0.0.3338... on . 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 , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1191-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- RaySearch Laboratories AB (publ)
- Product
- Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 and 14.0.0.3338 Software Version: RayStation 12A, 12A Service Pack 1 and 2 and 2023B
- 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
- 32
- 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: 0735000201054920220616, 0735000201067920221007, 0735000201073020230913 and 0735000201055620230630 GTIN: 07350002010549, 07350002010679, 07350002010730 and 07350002010556 Serial Numbers: 13.0.0.1547, 13.1.0.144, 13.1.1.89 and 14.0.0.3338 Software Revisions: RayStation 12A, 12A Service Pack 1 and 2 and 2023B Expiration Date: 2028-07-07
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1185-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1186-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1187-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1188-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1189-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1190-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1191-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1192-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1193-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1194-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1195-2025 | Class II | Ongoing | Voluntary: Firm initiated |
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