Stealthstation S7 Treatment Guidance System

Medtronic has identified an anomaly with the Stealth Station™ System Cranial Software biopsy depth gauge graphical display which presents during navigation in a cranial biopsy procedure. On June 9, 2021, a complaint was reported to Medtronic that during navigation in a cranial biopsy procedure, the user may encounter an anomaly with the biopsy depth gauge graphical display in the software. Between 01-Jan-2019 through 10-Sep-2021, Medtronic has received four (4) complaints, with one confirmed to be directly related to this software anomaly. The software can enter a state where the biopsy depth gauge is no longer synchronized with the rest of the navigational information on the screen and displays an inaccurate position of the biopsy needle.

In order for this software anomaly to occur, all of the following must happen:

• The biopsy trajectory is locked, and

• Guidance view is turned off or turned to a different view, and

• The crosshairs are repositioned by clicking the 2D or 3D image, and

• Guidance view is returned as an active view or

• The biopsy trajectory is locked, and

• The crosshairs are repositioned by clicking the 2D or 3D image, and

• Guidance view is turned off or turned to a different view, and

• Guidance view is returned as an active view if performed, these actions may cause the biopsy depth gauge graphical display to incorrectly depict the tip of the biopsy needle. the graphical depiction of the biopsy needle may appear in a position relative to the plan target that does not represent the actual physical position of the biopsy needle, which may result in potential biopsy of healthy tissue or damage to critical structures.

Recall start date: Nov 29, 2021