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 | If by mistake the initial pre-treatment imaging was performed BEFORE the HexaPOD was moved to the DRIVE (*START) position, iGUIDE offers the possibility to branch into a specific catch-up workflow, which was implemented to use the initial scan data. |
| Product | iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment. |
| Quantity | 20 |
| Distribution | IL, LA, Austria, Australia, Botswana, Germany, Denmark, France, India, Japan |
| Initiated | 2016-05-12 |
| Classified | 2016-05-23 |
| Terminated | 2021-07-16 |
| Recall number | Z-1705-2016 |
| 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-1705-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74087/
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