Reported Aug 4, 2021 · Terminated
RayStation (Radiation Treatment Planning System)
Raysearch Laboratories Ab
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: RAYSEARCH LABORATORIES AB · Sveavagen 9 · Stockholm, N/A · N/A
Is this the product you have?
RayStation (Radiation Treatment Planning System)
7 of 7 products
| # | Barcodes | Product as published |
|---|---|---|
| 1 | 07350002010174 | RayStation 9A, 9B, 9B SP1, 10A, 10A SP1, 10B and 11A, in combination with RayCare Model Numbers/ UDI: RayStation 9.0 (9.0.0.113) 07350002010174 |
| 2 | 07350002010266 | RayStation 9.1 (9.1.0.933) 07350002010266 |
| 3 | 07350002010297 | RayStation 9.1 Service Pack 1 (9.2.0.483) 07350002010297 |
| 4 | 07350002010303 | RayStation 10.0 (10.0.0.1154) 07350002010303 |
| 5 | 07350002010365 | RayStation 10.0 Service Pack 1 (10.0.1.52) 07350002010365 |
| 6 | 07350002010310 | RayStation 10.1 (10.1.0.613) 07350002010310 |
| 7 | 07350002010389 | RayStation 11.0 (11.0.0.951) 07350002010389 |
- Lot codes and dates
- Product name (build number) UDI-DI RayStation 9.0 (9.0.0.113) 07350002010174 RayStation 9.1 (9.1.0.933) 07350002010266 RayStation 9.1 Service Pack 1 (9.2.0.483) 07350002010297 RayStation 10.0 (10.0.0.1154) 07350002010303 RayStation 10.0 Service Pack 1 (10.0.1.52) 07350002010365 RayStation 10.1 (10.1.0.613) 07350002010310 RayStation 11.0 (11.0.0.951) 07350002010389
- Amount recalled
- 5 units
Where it was sold
Why it was recalled
Initial delivery positions will be set incorrectly when having setup beam(s) at the localization point.
This product could cause temporary or reversible health problems — stop using it.
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