Oncentra External Beam — Class II medical device recall Z-0604-2016
Terminated recall by Elekta, Inc., reported 2016-01-13, distributed nationwide. When using the option "Tumor Overlap Fraction" in VMAT planning it has been observed that in rare cases the sy
| Recall number | Z-0604-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2015-12-18 |
| Classified | 2016-01-06 |
| Reported by FDA | 2016-01-13 |
| Terminated | 2021-09-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CA, CN, DE, DK, ES, FI, FR, GB, GR, IN, IT, JP, KR, NL, NO, PL, SE |
| Quantity | 154 |
Product
Oncentra External Beam - VMAT - Radiation therapy planning system Product Usage: The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.
Reason for recall
When using the option "Tumor Overlap Fraction" in VMAT planning it has been observed that in rare cases the system does include an organ at risk as target volume. This could result in open MLC, and open jaws in areas away from the target volume.
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-0604-2016. 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.