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 collision risk when using XVI and external beam shaping devices. |
| Product | Synergy XVI The Elekta Synergy S is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner. |
| Quantity | 312 |
| Distribution | Worldwide Distribution: US (nationwide) including Puerto Rico and the states of: AL, AK, AZ, CA, CO, CT, FL, GA, IL, IA, KY, MD, MA, MI, MN, MS, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VT, VA, WA, WV, WI, DC, and Internationally to: Algeria, Australia, Austria, Belarus, Belgium, Brazil, Canada, Chile, China, Cyprus, Czech Republic, France, Germany, Greece, Hong Kong, India, Israel… |
| Initiated | 2013-11-25 |
| Classified | 2014-02-20 |
| Terminated | 2016-12-14 |
| Recall number | Z-1061-2014 |
| 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-1061-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67230/
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