Brainlab Issues Recall for Cranial Image-Guided Surgery System

Brainlab is recalling its cranial image-guided surgery system due to potential inaccuracies in the display compared with a patient’s anatomy.

The recall — designated as Class 1 by the FDA — involves 1,021 units distributed from May 1996 to May 2015, according to an FDA recall notice. The affected product was distributed in eight states.

The problem could lead to inaccurate, ineffective medical procedures, as well as serious life-threatening injuries or death, the FDA says.

Brainlab notified customers of the issue on April 22, 2013, and issued an update on May 29, 2015.

The company advised customers to adhere to the instructions for use supplement document “Measures to Improve Cranial Navigation Accuracy” when using the affected product.

Brainlab says affected customers’ software is being updated with an additional safety feature. The update is nearing completion, and the company is expediting the process.

There have been no serious injuries related to this recall reported to Brainlab by any hospital, company spokeswoman Ann Marie LaCasha said.

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