Class 1 recall: Brainlab AG Spine & Trauma 3D Navigation software may cause inaccurate display, dangerous mis-readings
The Food and Drug Administration issued a safety warning yesterday afternoon for the Brainlab Spine & Trauma 3D Navigation Software, which operates the Brainlab Spine & Trauma Navigation System to deliver images that can help surgeons safely navigate surgical tools and implants used before and during minimally invasive surgical procedures.
FDA said the company’s software has potential to send the wrong information to the display during a procedure which could cause the surgeon to inaccurately navigate surgical tools inside the patient.
Class 1 recalls are the most serious recalls and FDA says the device could cause the following problems:
· Damage to the patient’s body,
· A second, otherwise unnecessary, surgical procedure
· Serious life-threatening patient injuries or death
The safety warning said Brainlab notified users on March 1, 2019 with the following directives:
· Avoid workflow changes with already registered datasets, if possible. For intraoperative screw planning, avoid switching between the workflow application selections “3D Navigation Intraoperative Imaging” and “3D Navigation” during one patient treatment.
· After restarting the application with a previously registered dataset (crash restore or workflow change), always activate and deactivate the sub-menu “Orientation” once to ensure that the correct, expected view representations are displayed for the current session.
· Continue to follow instructions and warnings in the user guide, particularly regarding maintaining navigation accuracy and avoiding reference displacement.
Brainlab said it is halting distribution of the software once the updated version is released and available.
For more information, FDA says users should reference the Navigational Accuracy Errors Associated with Frameless Stereotaxic (Stereotactic) Navigation Systems: FDA Safety Communication, which includes recommendations for health care providers.
