January 10, 2019

FDA: Class I recall of Medtronic’s Synergy, Stealth Station S7 Cranial Software

By: Judy Mathias
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Editor’s Note

The Food & Drug Administration (FDA) on January 8 identified the recall of Medtronic’s Synergy Cranial Software and Stealth Station S7 Cranial Software as Class I, the most serious.

The Software is used with the Stealth Station Surgical Navigation System to provide detailed 3D images of a patient’s brain during neurosurgery.

Medtronic is recalling the Software because of reports of incorrect information displaying during biopsy procedures that could result in serious or life-threatening patient harm.

The model numbers are:

  • 9733763 with software versions 2.2.0, 2.2.5, 2.2.6, 2.2.7
  • 9735585 with software versions 3.0.0, 3.0.1, 3.0.2, 3.1.0

Manufacturing and distribution dates were August 31, 2011 to October 16, 2018.

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