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 | When DICOM is exporting an arc plan (VMAT, Dynamic Conformal of 3D Static Arcs) and using the Composite Field Sequencing (CFS) feature, the DICOM exported plan will not match the approved treatment plan. |
| Product | FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient contouring and viewing of treatment plan outputs. Also able to perform CT simulations and forward their information to the RTP System for dose calculation. |
| Quantity | 554 units |
| Distribution | Worldwide Distribution - US (nationwide)in the states of AK, CA, FL, MI, MN, MO, NJ, NY, NC, OH, PA, TN, VA,WA and Puerto Rico, Algeria, Antigua & Barbuda, Australia, Austria, Bahrain, Belarus, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech republic, Ecuador, Egypt, Estonia, France, Germany, Greece, India, Iraq, Israel, Italy, Japan, Kazakhstan, Malaysia, Malta, Mexico, Morocco, … |
| Initiated | 2014-08-18 |
| Classified | 2014-09-03 |
| Terminated | 2017-08-08 |
| Recall number | Z-2574-2014 |
| 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-2574-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68984/
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