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 | Order Status Remains Approved When Should Indicate Complete. |
| Product | MOSAIQ Oncology Information System |
| Quantity | 185 |
| Distribution | AK, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, WA, WI, WV, and WY Australia, Canada, Ireland, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, and United Kingdom |
| Initiated | 2018-08-03 |
| Classified | 2018-08-23 |
| Terminated | 2024-09-23 |
| Recall number | Z-2917-2018 |
| 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-2917-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80764/
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