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Medtronic Starts Out New Year With Class I Recall Of Cranial Software

 
• By Shawn M. Schmitt

The device maker recalled its Synergy Cranial and StealthStation S7 Cranial software “due to the potential inaccuracies caused by the Biopsy Depth Gauge Cycle View,” the US FDA said on 6 January.

A logo sign outside of a facility occupied by Medtronic.
• Source: Alamy

A recall by Medtronic PLC of cranial software used with its StealthStation surgical navigation system has been labeled as high-risk class I by the US Food and Drug Administration.

The company recalled its Synergy Cranial and StealthStation S7 Cranial software on 11 November “due to the potential inaccuracies caused by the Biopsy Depth Gauge Cycle View,” the FDA

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