Medical Device Safety and Recalls: Navigational Accuracy Errors Associated with Frameless Stereotaxic Navigation Systems: FDA Safety Communication

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Navigational Accuracy Errors Associated with Frameless Stereotaxic Navigation Systems: FDA Safety Communication

The FDA has issued a Safety Communication to make health care providers aware of possible navigational accuracy errors that may occur when using frameless stereotaxic navigation systems. Be aware that based on current information, the FDA believes the overall benefits of using frameless stereotaxic navigation systems continue to outweigh the risks and the Agency has not determined that any particular system carries greater risk than others.

This communication also contains recommendations for surgeons to consider to help mitigate associated risks to patients, including repeatedly assessing the navigational accuracy throughout a procedure when using a frameless surgical navigation system.

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