Brainlab, a privately held German medical technology firm in Munich, has recalled its Spine and Trauma 3D Navigation 1.0 Software because of a fault that could cause surgeons to see inaccurate information, which could, as a result, lead to serious injury or even death, FDA said in a notice.
The software is being recalled due to the “potential for incorrect information to display during surgery that may prevent the surgeon from accurately navigating surgical tools inside the patient,” according to the release from the FDA.
This may lead to damage of a patient’s body, the need for a second surgical surgery, or life-threatening patient injuries or death, FDA said.
According to the release, the company has recalled software that was manufactured and distributed between May 2018 and February 2019, with a HAW code. A total of 60 devices are being recalled in the US.
Those affected may include health care provider using the Brainlab Spine and Trauma 3D Navigation Software, as well as patients who undergo with the use of the navigation software.
Brainlab notified consignees of the issue on March 1, 2019, and directed consignees to:
- “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 plans to stop distributing the spine and trauma navigation software as soon as an updated version is released, FDA said.