MOSAIQ Oncology Information System MOSAIQ is an oncology information… — Class II medical device recall Z-0557-2016
Terminated recall by Elekta, Inc., reported 2016-01-06, distributed nationwide. Incorrect drug dosage due to "Age Limit" and patient weight data item issue.
| Recall number | Z-0557-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2015-12-09 |
| Classified | 2015-12-29 |
| Reported by FDA | 2016-01-06 |
| Terminated | 2022-09-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BH, CA, CZ, DE, GB, HU, SA, SE, TR |
| Quantity | 399 |
Product
MOSAIQ Oncology Information System 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 wherever radiotherapy and/or chemotherapy are prescribed.
Reason for recall
Incorrect drug dosage due to "Age Limit" and patient weight data item issue.
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-0557-2016. 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.