Brainlab AG issued a Class 1 recall of its Brainlab Spine & Trauma 3D Navigation 1.0 software.
Four things to know:
1. Brainlab recalled the software for its spine and trauma navigation because it could display incorrect information during surgery. As a result, the surgeon would not have accurate surgical tool navigation, which could lead to damage, reoperation or life-threatening injuries.
2. The recalled software was manufactured and distributed from May 2018 to February 2019, and there are 60 units in the U.S.
3. Brainlab told users about the problem March 1 and recommended they avoid switching between workflow application selections during surgery. The company also told users not to make workflow changes to registered datasets and to activate and deactivate the "Orientation" sub-menu after a restart on a previously registered dataset to ensure the correct setting.
4. The company will stop distributing the current software when an updated version is available.