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 | MOSAIQ does not re-calculate the agent volume when the user changes the ordering dose (to other than what was calculated) prior to saving the order. |
| Product | MOSAIQ MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used where ever radiotherapy and/or chemotherapy are prescribed. |
| Quantity | 101 |
| Distribution | Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AL, AK, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, IA, KY, LA, ME, MD, MA, MI, MO, MT, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TX, VT, VA and WA,. and the countries of Australia, Canada, New Zealand and United Kingdom. |
| Initiated | 2014-05-29 |
| Classified | 2014-06-25 |
| Terminated | 2021-07-16 |
| Recall number | Z-1869-2014 |
| 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-1869-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68386/
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