Company: Medtronic Surgical Navigation Technologies, Inc.
Date of Enforcement Report: 4/20/05
Class: II
PRODUCT
Stealth Station Cranial Application v.4.5. Catalog Numbers: 960-201 and 9730888. Recall # Z-0711-05.
REASON
The Stealth Station Cranial Application Version 4.5 contains a software anomaly, which may present a hazard to the patient. The user has the option to create and make visible supplemental contours of specific anatomy viewable during a surgical procedure. Activation of a new tip extension feature will move the location of these contours in such a manner that they no longer correlate to the intended anatomy. Potential consequences may include improper resection of the brain tissue.
CODE
Software v.4.5.
RECALLING FIRM
Medtronic Surgical Navigation Technologies, Inc., Louisville, CO, by letters dated January 28, 2005 and February 2, 2005. Firm initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE
44 systems.
DISTRIBUTION
Nationwide and Internationally.
