Elekta Synergy XVI — Class II medical device recall Z-0931-2013
Terminated recall by Elekta, Inc., reported 2013-03-20, distributed nationwide. The DICOM tags do not contain sufficient information for XVI to identify the different volumes that have the s
| Recall number | Z-0931-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2012-12-19 |
| Classified | 2013-03-10 |
| Reported by FDA | 2013-03-20 |
| Terminated | 2021-07-14 |
| Distributed | Nationwide (US) |
| Quantity | 164 |
Product
Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.
Reason for recall
The DICOM tags do not contain sufficient information for XVI to identify the different volumes that have the same name.
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-0931-2013. 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.