Focal SIM Planning of radiation therapy — Class II medical device recall Z-2002-2012
Terminated recall by Elekta, Inc., reported 2012-07-18, distributed nationwide. Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates o
| Recall number | Z-2002-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Norcross, GA, United States |
| Recall initiated | 2012-06-21 |
| Classified | 2012-07-12 |
| Reported by FDA | 2012-07-18 |
| Terminated | 2014-04-01 |
| Distributed | Nationwide (US) |
| Quantity | 38 units |
Product
Focal SIM Planning of radiation therapy
Reason for recall
Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports.
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-2002-2012. 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.