Stealthstation S7 – Software, Cranial

Notification to address two software anomalies under specific conditions, these anomalies can result in the potential for inaccurate/conflicting information to be displayed during cranial biopsy, tumor resection, shunt placement, and nexframe™ dbs procedures.

-  under certain situations, the biopsy depth gauge graphic on the screen may not display accurately.

- under certain situations, the "distance to target" text that displays on the screen may not display accurately.

If the user encounters either software anomaly and proceeds based on the inaccurate information, there is the potential to navigate too shallow or deep to the intended target. During a cranial biopsy procedure, this issue can potentially lead to biopsy of normal brain tissue, a non-diagnostic biopsy, or unintended tissue damage including the potential for life-threatening injury (hemorrhage or permanent neurological injury) which could lead to death.

In addition to potential serious injury during cranial biopsy, either anomaly may result in the potential for a prolonged procedure, the need for an additional surgical procedure, or tissue injury from unintended additional pass of a device.

Recall start date: April 13, 2023