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Brainlab AG recalls ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery.
Recalled June 11, 2014 · FDA recall Z-1707-2014 · 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. · FDA Class II
Units
40 systems (worldwide)
Sold at
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
Description
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.
Product
ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery.
Manufacturer(s)
Brainlab AG
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →