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 | A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling |
| Product | Oncentra Brachy radiation therapy planning system software. |
| Quantity | 336 systems |
| Distribution | Distribution US nationwide, including Puerto Rico. There was no military/government distribution. |
| Initiated | 2022-12-05 |
| Classified | 2022-12-15 |
| Recall number | Z-0719-2023 |
| 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-0719-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91224/
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