FOCAL Sim Workstation — Class II medical device recall Z-2574-2014
Terminated recall by Elekta, Inc., reported 2014-09-10, distributed nationwide. When DICOM is exporting an arc plan (VMAT, Dynamic Conformal of 3D Static Arcs) and using the Composite Field
| Recall number | Z-2574-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2014-08-18 |
| Classified | 2014-09-03 |
| Reported by FDA | 2014-09-10 |
| Terminated | 2017-08-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BG, BH, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DZ, EC, EE, EG, ES, FR, GB, GR, IL, IN, IQ, IT, JP, KR, MA, MT, MX, MY, NL, NZ, PK, PT, RO, RU, SA, SG, TH, TR, ZA |
| Quantity | 554 units |
Product
FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient contouring and viewing of treatment plan outputs. Also able to perform CT simulations and forward their information to the RTP System for dose calculation.
Reason for recall
When DICOM is exporting an arc plan (VMAT, Dynamic Conformal of 3D Static Arcs) and using the Composite Field Sequencing (CFS) feature, the DICOM exported plan will not match the approved treatment plan.
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-2574-2014. 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.