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 | It is possible that a change to an Order Set will not be saved in the current open Care Plan. This can result in a wrong chemo dose in the order. |
| Product | MOSAIQ Oncology Information System |
| Quantity | 383 |
| Distribution | Worldwide distribution. US nationwide, Antigua and Barbuda, Australia, Austria, Bahamas, Bahrain, Canada, Czech Republic, Germany, Hungary, South Africa, Spain, Sweden, Turkey, and United Kingdom |
| Initiated | 2016-07-15 |
| Classified | 2016-07-27 |
| Recall number | Z-2293-2016 |
| 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-2293-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74668/
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