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 | An error in NVIDIA GPU (Graphics Processing Unit) card drivers can occur for certain software programs. In a non-standard Citrix environment where the GPU settings are configured with a virtual Citrix graphics board (graphics card) an erroneous calculation may be allowed. |
| Product | Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation 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. The system functionality can be configured based on user needs |
| Quantity | 741 units |
| Distribution | Nationwide Distribution to AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, LA, MN, MD, MA, MI, MS, MT, NJ, NY, NC, NV, OH, OK, OR, PA, RI, TN, TX, VA, VT, VI, WA, WI, and Washington D.C. |
| Initiated | 2017-01-18 |
| Classified | 2017-04-12 |
| Terminated | 2019-06-12 |
| Recall number | Z-1815-2017 |
| 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-1815-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76342/
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