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 | Monaco is using the incorrect energy when optimizing and calculating dose. |
| Product | Monaco Radiation Treatment Planning System (RTP) System |
| Quantity | 76 (7 US, 69 OUS) |
| Distribution | IA, IN, NY, OH, TX, WI. Internationally distributed to: Australia, Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, Netherlands, Sweden, Switzerland, United Kingdom. |
| Initiated | 2019-11-22 |
| Classified | 2019-12-12 |
| Recall number | Z-0670-2020 |
| 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-0670-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84330/
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