Class II — Elekta Inc
| Recalling firm | ELEKTA AB |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation. |
| Product | Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for: -contouring -image manipulation -simulation -image fusi… |
| Quantity | 30 units |
| Distribution | Worldwide Distribution - US Nationwide in the states of WI, OH, NY, OH, IN, IA, TX, and countries of Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, Netherlands, Sweden, UK |
| Initiated | 2019-09-04 |
| Classified | 2019-09-25 |
| Recall number | Z-2560-2019 |
| 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 — Elekta Inc (Z-2560-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83692/
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