Class II — Elekta Limited
| 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 | In TSM (Treatment Session Manager) Motion Monitoring workflows, under certain conditions there can be a mismatch between the contour data overlay with respect to the motion monitoring images of the monitored structure. |
| Product | Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571 |
| Quantity | 26 units |
| Distribution | US distribution to IA, NY, PA, TX, WI. International distribution to Australia, Canada, China, Denmark, Germany, Hong Kong, Italy, Netherlands, Sweden, Switzerland, Turkey, United Kingdom. |
| Initiated | 2020-05-21 |
| Classified | 2020-06-08 |
| Terminated | 2024-08-19 |
| Recall number | Z-2297-2020 |
| 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 Limited (Z-2297-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85600/
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