MOSAIQ Oncology Information System Version 2 — Class II medical device recall Z-0686-2019
Terminated recall by Elekta, Inc., reported 2019-01-02. If a Setup field (CT, kV, MV or MVCT) is created by COPYING a treatment field or another setup field, then the
| Recall number | Z-0686-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2018-12-04 |
| Classified | 2018-12-27 |
| Reported by FDA | 2019-01-02 |
| Terminated | 2026-02-23 |
| Countries outside the US | AR, AU, BE, BR, CA, CH, CN, CO, DE, DK, DZ, ES, FR, GB, ID, IE, IL, IN, IR, IT, JP, LB, LV, MA, MX, MY, NL, NO, NZ, PE, PH, PL, PT, SA, SE, SG, SI, TH, TR, TW, VN, ZA |
| Quantity | 551 units |
| UPC / GTIN / UDI-DI | 00858164002091 |
Product
MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery
Reason for recall
If a Setup field (CT, kV, MV or MVCT) is created by COPYING a treatment field or another setup field, then the copied field will have the same isocenter as the parent and that isocenter may not be the correct isocenter for imaging when it is sent to the machine.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0686-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.