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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.
In 2017, FDA communicated awareness that some healthcare providers experienced navigational accuracy errors during surgical procedures when using frameless stereotaxic navigation systems, including in orthopedic procedures. Some of these errors led to patient deaths, serious or life-threatening injuries and inaccurate, aborted or prolonged medical procedures.
Based on its analysis at the time, FDA did not believe that there are many factors that contribute to these errors, nor that any particular system carries greater risk than others. In its issued safety communication, FDA noted a belief that the overall benefits of these devices continue to outweigh the risks in appropriately selected patients when used by properly trained surgeons.
Source: FDA.gov
