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 | A patient was seriously mistreated after a user made and saved an inadvertent change to the definition of a treatment filed in MOSAIQ. |
| Product | MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It lets users supply electronic patient charts and assemble care plans, order diagnostic tests, and prescribe medications. It also lets users import, view, annotate, manipulate, enhance, manage, and archive images. |
| Quantity | 300 |
| Distribution | Worldwide distribution: USA (nationwide) and country of Canada. |
| Initiated | 2012-09-18 |
| Classified | 2012-10-30 |
| Terminated | 2013-06-06 |
| Recall number | Z-0169-2013 |
| 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-0169-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63335/
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