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 | If screws are not properly tightened with a torque wrench they may become loose over time. |
| Product | HexaPOD evo RT Couchtop. To support and aid in positioning a patient during radiation therapy. |
| Quantity | 266 |
| Distribution | Worldwide Distribution-USA including DC and the states of AZ, CA, CT, FL, GA, IL, HI, KY, MD, MA, MI, MS, MO, NJ, NY, NH, NC, ND, OH, OK, OR, PA, SC, TX, VA, WA, WI, and WY, and the countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Kazakhstan, Mexico, Netherlands, N… |
| Initiated | 2014-04-17 |
| Classified | 2014-04-25 |
| Terminated | 2015-01-29 |
| Recall number | Z-1514-2014 |
| 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-1514-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68088/
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