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 | Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple prescriptions with forced densities. |
| Product | Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy. |
| Quantity | 154 units |
| Distribution | Worldwide Distribution -- US, including the states of CA, IN, MI, MO, TX and WI; and, the countries of Australia, Canada, Germany, Greece, India, Netherlands, New Zealand, Turkey, and the UK. |
| Initiated | 2015-09-15 |
| Classified | 2015-10-07 |
| Terminated | 2017-04-04 |
| Recall number | Z-0112-2016 |
| 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-0112-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72221/
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