MOSAIQ¿ Oncology Information System and Sequencer MOSAIQ is an… — Class II medical device recall Z-0821-2019
Ongoing recall by Elekta, Inc., reported 2019-02-20, distributed nationwide. There is a potential that Wedge IDs were not included in the DICOM RT PLAN sent from the TPS, which will cause
| Recall number | Z-0821-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2018-12-13 |
| Classified | 2019-02-08 |
| Reported by FDA | 2019-02-20 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00858164002084, 00858164002091, 00858164002107, 00858164002220, 00858164002237 |
Product
MOSAIQ¿ Oncology Information System and Sequencer 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
There is a potential that Wedge IDs were not included in the DICOM RT PLAN sent from the TPS, which will cause the field in MOSAIQ to be created with no wedge. Treatment of a field without the planned wedge will receive more dose than the treatment plan indicates.
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-0821-2019. 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.