Class 2 Device Recall Stereotaxic Navigation System

• Date Initiated by Firm: January 28, 2005
• Date Posted: April 16, 2005
• Recall Status: Terminated on April 15, 2005
• Recall Number: Z-0711-05
• Recall Event ID: 31133
• 510(K)Number: K954276
• Product Classification: Neurological Stereotaxic Instrument - Product Code HAW
• Product: Stealth Station Cranial Application v.4.5
• Code Information: Catalog Numbers: 960-201 and 9730888. Cranial Application software v.4.5.
• Recalling Firm/ Manufacturer: Medtronic Surgical Navigation Technologies, Inc; 826 Coal Creek Cir; Louisville CO 80027-9710
• For Additional Information Contact: Customer Support Service Center; 800-595-9709
• Manufacturer Reason for Recall: The Stealth Station Cranial Application Version 4.5 contains a software anomaly, which may present a hazard to the patient.
• FDA Determined Cause: Other
• Action: Customers were sent notification letters dated 01/28/05 and 02/02/05.
• Quantity in Commerce: 53 systems with software version 4.5
• Distribution: Domestic distribution: FL, CO, AZ, TX, AR, MT, OK, IL, PA, NY, LA, WI, NC, ND, CA, GA, AL, OR, WY, WA, OH, NV. Foreign distribution: Belgium, Czech Republic, China (Malaysia). No military or VA facilites.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HAW