FDA recall, , Moderate risk
RaySearch Laboratories RayStation/RayPlan Radiation Therapy Treatment Planning Systems
RayStation/RayPlan radiation therapy treatment planning system may not invalidate calculated radiation dose for certain regions of interest.
Summary by Recall Canary from the FDA notice
What happened
RAYSEARCH LABORATORIES AB, of Stockholm, Sweden, is recalling RayStation/RayPlan radiation therapy treatment planning systems. The 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.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
Product details
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
- UDI-DI
- 07350002010426
- 07350002010495
- 07350002010501
- 07350002010600
- 07350002010570
RayStation/RayPlan
- UDI-DI
- 07350002010778
- Model/Catalog number
- 16.0.0
- Software version
- RayStation 2024B
- UDI-DI
- 07350002010549
- 07350002010679
- 07350002010730
- Model/Catalog number
- 13.0.0.1547
- 13.1.0.144
- 13.1.1.89
- Software version
- RayStation 12A, RayStation 12A SP1, RayStation 12A SP2
- UDI-DI
- 07350002010471
- Model/Catalog number
- 10.1.1
- Software version
- RayStation 10B SP1
- UDI-DI
- 07350002010822
- 07350002010945
- Model/Catalog number
- 17.0.0
- 17.0.1
- Software version
- RayStation v2025, RayStation v2025 SP1
- UDI-DI
- 07350002010761
- 07350002010808
- Model/Catalog number
- 15.2.0
- 15.1.3
- Software version
- RayStation 2024A SP1, RayStation 2024A SP2
- UDI-DI
- 07350002010556
- 07350002010723
- 07350002010884
- Model/Catalog number
- 14.0.0
- 15.0.0
- 15.1.3
- Software version
- RayStation 2023B, RayStation 2024A, RayStation 2024A SP3
RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatment Planning System
- UDI-DI
- 07350002010310
RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStation 11A, RayStation 11A SP1, RayStation 11A SP2, RayStation 11A SP3. Radiation Therapy Treatment Planning System
- UDI-DI
- 07350002010389
- 07350002010433
- 07350002010440
- 07350002010631
Recall details
- Company began the recall
- Sold in
Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS
- Company
- RAYSEARCH LABORATORIES ABStockholm, Sweden
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98117
- Recall numbers
- Z-1102-2026 to Z-1110-2026
All recalls from RAYSEARCH LABORATORIES AB
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
