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 | Contours are not handled correctly if the CT dataset contains slices with DICOM Z coordinates of xx.x50mm. |
| Product | Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. |
| Quantity | 2148 |
| Distribution | Worldwide Distribution - US including AK, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MD, MA, MI, MN, MO, MT, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, SD, TX, UT, VA, WA, WI, Puerto Rico and Internationally to Algeria, Antiqua & Barbuda, Argentina, Australia, Austria, Bahrain, Belarus, Botswana, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cuba, Cyprus, Czech Republic, Ecuador, Egypt, Estoni… |
| Initiated | 2016-11-17 |
| Classified | 2016-11-28 |
| Terminated | 2021-12-17 |
| Recall number | Z-0668-2017 |
| 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-0668-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75718/
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