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 | RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy. |
| Product | RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software |
| Quantity | 19 units (16 units domestically & 3 units internationally) |
| Distribution | OH, MD, NJ, WA, IL, MA, FL, Spain, United Kingdom, Italy, |
| Initiated | 2014-02-06 |
| Classified | 2014-03-31 |
| Terminated | 2017-02-17 |
| Recall number | Z-1308-2014 |
| 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-1308-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67511/
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