Drug recall
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number…
FDA recall event 96156 · Class II · RAYSEARCH LABORATORIES AB
Key facts
| Event ID | 96156 |
|---|---|
| Recall numbers | Z-1185-2025, Z-1186-2025, Z-1187-2025, Z-1188-2025, Z-1189-2025, Z-1190-2025, Z-1191-2025, Z-1192-2025, Z-1193-2025, Z-1194-2025, Z-1195-2025 |
| Recalling firm | RAYSEARCH LABORATORIES AB |
| Product type | Devices |
| Products | 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…, Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 10.1.0.613 and 10.1.1.54 Software Version: RayStation 10B and 10B Service Pack 1, Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 and 12.3.0.119 Software Version: RayStation 11B…, 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…, Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4 and 4.7.6.7 Software Version: RayStation 4.5.1… and 6 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Jan 16, 2025 |
| Report date | Feb 26, 2025 |
| City | Stockholm |
| Country | Sweden |
| FEI number | 3007774465 |
At a glance
- 10–99 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: