Brainlab Cranial Navigation Systems Recall

Brainlab Cranial IGS System is a medical device that shows the area of interest and the position of an instrument relative to the patient’s anatomy to enable minimally invasive surgical procedures, for example, interventional radiology to remove a brain tumor.  According to the FDA: “Brainlab is recalling the Cranial IGS System due to potential inaccuracies in the display by the navigation system compared to the patient anatomy. This could lead to inaccurate, ineffective medical procedures, and serious life-threatening injuries including death.”

This recall includes about 1021 units of the following:

  1. the Brainlab Cranial IGS System and
  2. Brainlab Cranial Navigation Systems (all existing versions before Cranial 3.0)

Distribution dates for these products are May 1996 to May 2015.

Brainlab notified doctors, hospitals, clinics and other customers of the issue on April 22, 2013 and issued an update on May 29, 2015. The notifications urged customers to adhere to the Instructions for Use supplement document “Measures to Improve Cranial Navigation Accuracy” when using the affected product. Updated software installation started in September 2015.

The recalled brainlab products were distributed in the following states:

  • Arkansas (AR)
  • California (CA)
  • Colorado (CO)
  • Maryland (MD)
  • North Carolina (NC)
  • Ohio (OH)
  • Pennsylvania (PA)
  • Texas (TX).

If you think your loved one was harmed by this product and want to sue for compensation and justice, contact our law firm. You can contact our law firm about a lawsuit by submitting our free consultation form (click here) or by calling 1-888-377-8900 (toll free).

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Category: Product Liability
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