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 | Terminated |
| Reason | If Improve Target Dose was chosen as an optimization model in a previous treatment session, Monaco® will automatically use this optimization model again when proceeding with the online plan adaptation of a completion plan when it should not. |
| Product | Monaco Radiation Treatment Planning (RTP) System |
| Quantity | 14 devices |
| Distribution | Domestic distribution to Wisconsin, Texas. International distribution to Denmark, England, Germany, Netherlands, Sweden. |
| Initiated | 2019-02-08 |
| Classified | 2019-02-27 |
| Terminated | 2024-08-19 |
| Recall number | Z-0965-2019 |
| 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-0965-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82072/
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