FDA Device recall Z-0050-2018
Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning softwa…
- FDA Device
- Class II
- terminated
- Published 2017-11-01
On 2017-11-01 the FDA classified a Class II recall of Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning softwa… by Nucletron Bv, citing incorrect source step size may occur in the software plans.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0050-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-08-10 |
| Published | 2017-11-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Nucletron Bv |
| Distribution | US |
Product
Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment and may be used to administer treatments after review and approval by qualified medical personnel.
Reason
Incorrect source step size may occur in the software plans
Identifiers
| code_info | Versions 4.5, 4.5.1, and 4.5.2. |
|---|
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-0050-2018%22
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