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U.S. Department of Health and Human Services

Class 2 Device Recall StealthStation System

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  Class 2 Device Recall StealthStation System see related information
Date Initiated by Firm July 18, 2016
Create Date August 02, 2016
Recall Status1 Terminated 3 on December 01, 2016
Recall Number Z-2318-2016
Recall Event ID 74715
510(K)Number K050438  
Product Classification Neurological stereotaxic Instrument - Product Code HAW
Product MACH Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes.

Product Usage:
The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
Code Information Model Number 9730888. All lot numbers manufactured by Medtronic Navigation are affected.
Recalling Firm/
Manufacturer
Medtronic Navigation, Inc.
826 Coal Creek Cir
Louisville CO 80027-9710
For Additional Information Contact Tom Reimann
720-890-3241
Manufacturer Reason
for Recall
Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.
FDA Determined
Cause 2
Software design
Action Medtronic sent an Urgent Medical Device Safety Alert to all affected customers on August 20, 2016. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached confirmation form and return to RS.NavFCA@medtronic.com or fax it to Medtronic Technical Service at 651-367-7075. For questions contact Neurologica Technical Support at 1-888-564-8561 (US/Canada) or +1-978-564-8561 (International) or email support@neurologica.com
Quantity in Commerce 27 in total
Distribution Worldwide Distribution - US Nationwide in the state of: NY, AZ, AR, NC, CA, OH, MI, IN, MA, TX, OH, OR, CO, MO, UT, IL. and the countries of: India, Australia, and Russian Federation.
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 and Original Applicant = MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES
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