A medical device created by Brainlab and marketed as easy-to-use, intuitive, precise and tailored to surgeons’ needs has been recalled by the U.S. Food and Drug Administration.

Cranial-navigation systems sold by Brainlab, a German manufacturer that develops software-based applications for brain surgeons in addition to surgeons in other disciplines such as orthopedic, otolaryngology and spine, can cause serious injury or death because of inaccuracies in the product’s real-time display.

“The class I recall – the most serious type issued by the FDA – indicates that use of all existing versions of Brainlab’s Cranial IGS System and Cranial Navigation Systems (before version 3.0) could lead to significant patient harm,” states an article in Outpatient Surgery Magazine, which notes the company reissued a warning to users in May 2015 that first was issued in two years prior.

The recall covers versions of cranial-navigation systems preceding 3.0, as well as Image-Guided Surgery (IGS) systems distributed between May 1996 and May 2015. The total number of units affected is 1,021 in eight states (Arkansas, California, Colorado, Maryland, North Carolina, Ohio, Pennsylvania and Texas,) according to the FDA.

Here is what Brainlab’s Web site says about the efficiency of the device: “With digital patient data uploaded to the Brainlab Cranial neuronavigation application in the O.R., surgeons can identify their approach before making an incision. Surgeons are guided through procedures, helping to keep skull openings small and minimize damage to healthy structures.”

The inaccuracy is that the digital visualization does not mirror patient anatomy.

Reporting Brainlab Adverse Problems

Brainlab has set up a hotline at (800) 597-5911 to report adverse problems. Both consumer and healthcare providers also can report issues to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

So far, no patient incidents have been reported, said Ann Marie LaCasha, Brainlab’s director of corporate marketing.

“Brainlab considers patient safety to be our top priority,” LaCasha told Medial Design Technology magazine.

An update aimed at fixing the inaccuracy will come with a built-in safety feature, LaCasha said.

“With the FDA reclassifying the recall to Class I, Brainlab is expediting this process,” she said.