Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estima

U.S. FDA — Device Enforcement · Netherlands · 2017-08-10 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0050-2018
Date of alert: 2017-08-10
Country / jurisdiction: Netherlands
Risk level: Class II
Risk type: recall
Brand: Nucletron BV
Product category: device
Product type: Devices

Reported risk: Incorrect source step size may occur in the software plans

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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