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 using more than one plan in a treatment course, the Total dose display in Dose tracking may be incorrect. There may be a mismatch between the fractions that appear as selected in the Treatment course list in Dose tracking and the fractions that are included in the dose summation. The issue only affects RayTreat users and only the Total dose option. Accumulation and other options in Dose tracking are correct. |
| Product | RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs |
| Quantity | N/A |
| Distribution | Domestic: TN |
| Initiated | 2021-04-07 |
| Classified | 2021-05-14 |
| Terminated | 2023-06-02 |
| Recall number | Z-1598-2021 |
| 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-1598-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87868/
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