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 | Edits to Particle field definition parameters may not be saved when the field definition window is saved. |
| Product | MOSAIQ Oncology Information System The product is used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be use wherever radiotherapy and chemotherapy are prescribed. |
| Quantity | 47 |
| Distribution | Worldwide Distribution-US (nationwide) to states of: FL, IL, MO, NJ, OH, OK, TN, TX, VA, and countries of: Italy, Japan, South Korea, Sweden and United Kingdom. |
| Initiated | 2016-12-02 |
| Classified | 2016-12-09 |
| Terminated | 2021-11-05 |
| Recall number | Z-0731-2017 |
| 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-0731-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75853/
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