Brainlab AG recalls spine and trauma 3-D navigation software

Brainlab AG announced it recalled its Spine & Trauma 3D Navigation 1.0 software because the display may be inaccurate and can result in user misinterpretation, according to a recall release from the FDA.

According to the release, the FDA classified the announcement as a class I recall. On March 1, Brainlab recalled the spine and trauma navigation software manufactured and distributed between May 2018 and February 2019, with a HAW product code. The navigation provides patient images that assist surgeons in the accurate navigation of surgical tools and implants used before and during minimally invasive procedures.

Brainlab recalled the navigation software because incorrect information may display during surgery and prevent surgeons from accurately navigating surgical tools inside a patient. This may lead to damage of a patient’s body, the need for a second surgical procedure, or life-threatening patient injuries or death. Those affected may include health care providers who use the Brainlab spine and trauma navigation software and patients who undergo surgery with the use of the navigation software.

The company will stop distribution of this navigation software when an updated version is released and ready for distribution.

Reference:

www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm636071.htm?utm_campaign=2019-04-15%20Brainlab%20AG%20Recalls%20Spine%20%26%20Trauma%203D%20Navigation%20Due%20to%20Inaccurate%20Display&utm_medium=email&utm_source=Eloqua