Focal Sim radiation therapy treatment planning system — Class II medical device recall Z-1244-2015
Terminated recall by Elekta, Inc., reported 2015-03-11, distributed nationwide. Incorrect CT to ED when using the Monaco Image Statistics Tool.
| Recall number | Z-1244-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2014-12-19 |
| Classified | 2015-03-04 |
| Reported by FDA | 2015-03-11 |
| Terminated | 2017-08-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BG, BH, BR, CA, CL, CN, CO, CY, CZ, DE, DZ, EG, ES, FR, GB, GR, HR, ID, IL, IN, IQ, IT, JO, JP, KR, LK, LT, MA, MX, MY, NZ, PH, PT, RO, RS, RU, SG, SI, TH, TR, UA, VE, ZA |
| Quantity | 907 |
Product
Focal Sim radiation therapy treatment planning system
Reason for recall
Incorrect CT to ED when using the Monaco Image Statistics Tool.
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-1244-2015. 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.