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

Recall Z-0648-2016 — RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or oper

U.S. FDA — Device Enforcement · Germany · 2015-11-05 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0648-2016
Date of alert: 2015-11-05
Country / jurisdiction: Germany
Risk level: Class II
Risk type: recall
Brand: Brainlab AG
Product category: device
Product type: Devices

Reported risk: Large objects with fine resolution are potentially displayed cropped when imported into Adaptive Hybrid Surgery Analysis version 1.0.0

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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