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 | Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale. |
| Product | MOSAIQ Oncology Information System |
| Quantity | 64 units |
| Distribution | US: PA, AL, FL, IA UT OUS: Austria Belgium Bolivia Bosnia and Herzegowina Brazil Canada France Germany Hong Kong Italy Japan Korea, Republic of Malta Netherlands Panama South Africa Spain Taiwan Thailand Turkey Venezuela |
| Initiated | 2025-01-15 |
| Classified | 2025-02-11 |
| Recall number | Z-1162-2025 |
| 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-1162-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96153/
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