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

ExacTrac Vero is a Patient Positioning System for Radiation therapy. — recall Z-1929-2016

U.S. FDA — Device Enforcement · Germany · 2016-05-04 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1929-2016
Date of alert
2016-05-04
Country / jurisdiction
Germany
Risk level
Class II
Risk type
recall
Brand
Brainlab AG
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Distributed in the states of Florida, New York, Texas and Ohio, and in the countries of Belgium, France, Germany, Italy, Japan and South Korea.
Reported risk: Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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.