Synergy XVI The Elekta Synergy S is intended to be used for radiation… — Class II medical device recall Z-1061-2014
Terminated recall by Elekta, Inc., reported 2014-02-26, distributed nationwide. Potential collision risk when using XVI and external beam shaping devices.
| Recall number | Z-1061-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2013-11-25 |
| Classified | 2014-02-20 |
| Reported by FDA | 2014-02-26 |
| Terminated | 2016-12-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BR, CA, CL, CN, CY, CZ, DE, DZ, ES, FR, GB, GR, HK, IL, IN, IT, JP, KR, MX, MY, PK, PT, RU, SG, SK, TH, TW |
| Quantity | 312 |
| Model numbers | 4.2.1 |
Product
Synergy XVI The Elekta Synergy S is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
Reason for recall
Potential collision risk when using XVI and external beam shaping devices.
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-1061-2014. 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.