Brainlab recalled Spine & Trauma 3D Navigation 1.0 software manufactured and distributed between May 2018 and February 2019 due to the potential for incorrect information to display during surgery, preventing acccurate navigation of surgical tools inside the patient.
FDA has identified this as a Class I recall. Sixty devices were recalled in the U.S.
The software is used with Brainlab's navigation system that provides patient images to navigate surgical tools and implants used before and during minimally invasive procedures. The potential for user misinterpretation could potentially cause damage to the patient, the need for a second surgical procedure or patient death.
Brainlab will cease distribution of this software once an updated version is available and released. On March 1, 2019, the company directed customers to avoid workflow changes with already registered datasets and offered directions on settings and attention to instructions and warnings in the user guide.