RaySearch America Inc recalls
Every recall we track for RaySearch America Inc — 2 in all, from 2021–2022 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
2 recalls since 2017.
All FDA recall records for RaySearch America Inc since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 1 | 0 | 1 |
| 2022 | 0 | 0 | 1 | 0 | 1 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled RaySearch America Inc product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All RaySearch America Inc recalls
2 shown- Lower riskMedical device
RaySearch America Inc recalls RayStation 4-11B, and RayPlan 1, 2, 7-11B including some service packs: RayStation 4.0 (4.0.0.14) to RayStation 5
RaySearch America recalls RayStation 4-11B and RayPlan 1-8A software versions due to potential dose errors in radiation treatment planning. Affected users should contact RaySearch for details.
RaySearchFeb 11, 2022 - Lower riskMedical device
RaySearch America Inc recalls Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: 8B, 8B SP1, 8B
RaySearch America recalls RayStation software versions 8.1-10.1 for incorrect radiation treatment planning. The software bug may cause unsafe treatment plans if deep learning segmentation is used. Affected models include 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10A, 10A SP1, 10B.
RaySearch AmericaJan 22, 2021
RaySearch America Inc recall questions
How many recalls has RaySearch America Inc had?
2 recalls from RaySearch America Inc are on record with U.S. safety agencies, from 2021–2022.
What is the most recent RaySearch America Inc recall?
RaySearch America Inc recalls RayStation 4-11B, and RayPlan 1, 2, 7-11B including some service packs: RayStation 4.0 (4.0.0.14) to RayStation 5, dated Feb 11, 2022. Every RaySearch America Inc recall is listed on this page, newest first.
What should I do if I have a recalled RaySearch America Inc product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new RaySearch America Inc recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.