MOSAIQ — Class II medical device recall Z-1597-2020
Ongoing recall by Elekta Impac Software, reported 2020-04-01. The user may inadvertently enter Metric values into Height and Weight fields labeled with US Standard Units.
| Recall number | Z-1597-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta Impac Software, Sunnyvale, CA, United States |
| Recall initiated | 2019-09-24 |
| Classified | 2020-03-26 |
| Reported by FDA | 2020-04-01 |
| Quantity | 3,732 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00858164002077, 00858164002084, 00858164002091, 00858164002107, 00858164002220, 00858164002251, 00858164002282, 00858164002305, 00858164002312, 00858164002329 |
Product
MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery.
Reason for recall
The user may inadvertently enter Metric values into Height and Weight fields labeled with US Standard Units.
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-1597-2020. 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.