MOSAIQ MOSAIQ is an image-enabled electronic medical record system — Class II medical device recall Z-0169-2013
Terminated recall by Elekta, Inc., reported 2012-11-07, distributed nationwide. A patient was seriously mistreated after a user made and saved an inadvertent change to the definition of a tr
| Recall number | Z-0169-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Norcross, GA, United States |
| Recall initiated | 2012-09-18 |
| Classified | 2012-10-30 |
| Reported by FDA | 2012-11-07 |
| Terminated | 2013-06-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 300 |
Product
MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It lets users supply electronic patient charts and assemble care plans, order diagnostic tests, and prescribe medications. It also lets users import, view, annotate, manipulate, enhance, manage, and archive images.
Reason for recall
A patient was seriously mistreated after a user made and saved an inadvertent change to the definition of a treatment filed in MOSAIQ.
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-0169-2013. 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.