Class II — RAYSEARCH LABORATORIES AB
| Recalling firm | RaySearch Laboratories AB (publ) |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | When calculating electron Monte Carlo dose with a very large number of histories, the dose calculation may be wrong |
| Product | RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (RayStation 6) . Intended Use: software system designed for treatment planning and analysis of radiation therapy |
| Quantity | 744 |
| Distribution | US Nationwide Distribution |
| Initiated | 2017-11-20 |
| Classified | 2019-07-03 |
| Terminated | 2023-08-08 |
| Recall number | Z-1930-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — RAYSEARCH LABORATORIES AB (Z-1930-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83152/
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