MOSAIQ Oncology Information Systems interfaced to Elekta Treatment… — Class II medical device recall Z-1944-2012
Terminated recall by Impac Medical Systems Inc, reported 2012-07-18, distributed in CT, GA, NJ, NY, VA. Impac Medical became aware of a problem with the recording of the Wedge Motor Units in MOSAIQ when it resumes
| Recall number | Z-1944-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Impac Medical Systems Inc, Sunnyvale, CA, United States |
| Recall initiated | 2012-06-08 |
| Classified | 2012-07-06 |
| Reported by FDA | 2012-07-18 |
| Terminated | 2013-06-19 |
| Distributed | CT, GA, NJ, NY, VA |
| Countries outside the US | BE, DK, FR, GB |
| Quantity | 11 affected |
Product
MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. An image enabled electronic medical record system used for oncology workflow management. Manufactured by: Impac Medical Systems 100 Mathilda Place, 5th floor Sunnyvale, Ca 94086
Reason for recall
Impac Medical became aware of a problem with the recording of the Wedge Motor Units in MOSAIQ when it resumes after a machine terminates/faults, the remaining Wedge MU was being erroneously set to zero.
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-1944-2012. 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.