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 | Potential for iGUIDE to incorrectly monitor the 3D position. |
| Product | iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2 |
| Quantity | 374 devices |
| Distribution | Nationwide distribution to AK, AL, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI. Worldwide distribution to Algeria, Argentina, Australia, Austria, Belgium, Botswana, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Egypt, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy,… |
| Initiated | 2019-06-19 |
| Classified | 2019-08-09 |
| Terminated | 2024-05-06 |
| Recall number | Z-2230-2019 |
| 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-2230-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83180/
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