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 | Unintended update of Dose and MU and Incorrect Assignment of Bolus. |
| Product | Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy. |
| Quantity | 154 |
| Distribution | CA, IN, MI,MO, TX, WI, Australia, Canada, Germany,m Greece, India, Netherlands, New Zealand, Turkey and United Kingdom |
| Initiated | 2015-10-16 |
| Classified | 2015-10-28 |
| Terminated | 2017-04-04 |
| Recall number | Z-0181-2016 |
| 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-0181-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72424/
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