Class I Recall of Medtronic Synergy Cranial Software and Stealth Station S7 Cranial Software

Published: 01/09/2019

  • Food and Drug Administration
Relevant To:
  • All Healthcare Organizations

Medtronic is recalling the 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 that could result in serious or life-threatening patient harm.

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

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