FDA-Device2014-06-11Class II
ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery.
Brainlab AG
Hazard
When using a specific plan update workflow in combination with a non-Brainlab treatment planning system (TPS), there is a possibility in ExacTrac 5.5.5 to generate an unintended blend of two initially separate plans of the same patient.
Sold states
Worldwide Distribution - US Nationwide in the states of AZ, AR, CA, FL, KY, MA, NE, NY, TN, TX and the countries of Argentina, Australia, Brazil, Finland, India, Japan, Netherlands, Oman, Russia, and Taiwan
Affected count
40 systems (worldwide)
Manufactured in
Kapellenstrasse 12, Feldkirchen, Germany
Products
ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1707-2014Don't want to check this manually?
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