FDA Device recall Z-0604-2016
Oncentra External Beam - VMAT - Radiation therapy planning system Product Usage: The Oncentra system is a radiation treatment planning soft…
- FDA Device
- Class II
- terminated
- Published 2016-01-13
On 2016-01-13 the FDA classified a Class II recall of Oncentra External Beam - VMAT - Radiation therapy planning system Product Usage: The Oncentra system is a radiation treatment planning soft… by Elekta, citing 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 resul….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0604-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-12-18 |
| Published | 2016-01-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Elekta |
| Distribution | US |
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
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.
Identifiers
| code_info | Versions 3.3 and higher |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0604-2016%22
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