April 16, 2019
FDA: Class I recall of Brainlab Spine & Trauma 3D Navigation Software
Editor's Note
The Food & Drug Administration (FDA) on April 15 identified the recall of Brainlab's Spine & Trauma 3D Navigation Software as Class I, the most serious.
The Software is being recalled because of the potential for incorrect information to display during surgery, which may prevent the surgeon from accurately navigating surgical tools inside the patient.
Manufacturing and distribution dates are May 2018 to February 2019.
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