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 | For the proton QA preparation module in RayStation 6 (including SP1 and SP2), if the snout position or gap is modified in the QA module, the dose in the QA module may be computed for a different setup than what is used for QA measurements. This could result in an incorrect dosage being provided to a patient. |
| Product | RayStation Product Usage: is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. |
| Quantity | 117 units |
| Distribution | US Nationwide Distribution - FL, WA, AZ, TN, MD, TX, FL, MI, Washington D.C. |
| Initiated | 2017-07-17 |
| Classified | 2018-01-16 |
| Terminated | 2018-08-29 |
| Recall number | Z-0380-2018 |
| 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-0380-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/78900/
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