Class I Recall of Brainlab AG Spine and Trauma 3D Navigation Software

Published: 04/16/2019

  • Food and Drug Administration
Relevant To:
  • All Healthcare Organizations

Brainlab is recalling the Spine & Trauma 3D Navigation Software due to the potential for incorrect information to display during surgery that may prevent the surgeon from accurately navigating surgical tools inside the patient. This may result in:

  • Damage to the patient’s body
  • A second, otherwise unnecessary, surgical procedure, or
  • Serious life-threatening patient injuries or death

Recalled Product Details:

  • Brainlab Spine & Trauma 3D Navigation 1.0
  • Product code: HAW
  • Manufacturing Dates: Ma

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