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Medtronic Recalls Cranial Software Due to Inaccuracies

Jan. 14, 2019

Medtronic is recalling its Synergy Cranial Software and StealthStation S7 Cranial Software used with the StealthStation Surgical Navigation System due to reports of incorrect information displaying during biopsy procedures.

The software provides 3D images of a patient's brain to help neurosurgeons navigate surgical tools and implants used during brain surgery. During a biopsy procedure, the software monitor may show that the tip of the surgical tool has not yet reached the planned target and may prevent the neurosurgeon from being able to accurately see the location of surgical tools in the patient's brain, the FDA said. 

The Class I recall applies to 5,487 devices in the U.S., manufactured between Aug. 31, 2011 to Oct. 16, 2018.

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