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U.S. Department of Health and Human Services

Class 2 Device Recall STEALTHSTATION TREATMENT GUIDANCE PLATFORM

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  Class 2 Device Recall STEALTHSTATION TREATMENT GUIDANCE PLATFORM see related information
Date Initiated by Firm July 15, 2013
Date Posted August 13, 2013
Recall Status1 Terminated 3 on January 29, 2014
Recall Number Z-1956-2013
Recall Event ID 65743
510(K)Number K992927  
Product Classification Neurological stereotaxic Instrument - Product Code HAW
Product StealthStation S7 Framelink Software version 5.4.

Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures.
Code Information Lot number(s): Not applicable; All kits containing the Framelink Software version 5.4 are affected by this corrective action.
Recalling Firm/
Manufacturer		 Medtronic Navigation, Inc.
826 Coal Creek Cir
Louisville CO 80027-9710
For Additional Information Contact Michael Blasco
720-890-3391
Manufacturer Reason
for Recall		 Medtronic Navigation, Inc. has initiated a field correction to their Framelink software version 5.4 which can be used on Medtronic Navigation StealthStation 57 and i7 systems or a Medtronic Planning Station due to the potential of discrepancy between the exam image and the displayed measurement or overlay under certain conditions of use.
FDA Determined
Cause 2		 Software design
Action A Field Safety Notice was sent on 7/15/13 to users informing them that the Framelink software version 5.4 has been revised to correct the software anomalies described in this letter. A new version will be installed on their system(s) by a Medtronic Navigation representative. Until the software upgrade has been installed on their system, do not use high resolution examinations (greater than 256 x 256). If users are not sure of the exam resolution being used, firm recommend contacting the hospital imaging department or local Medtronic Navigation representative for assistance. Medtronic representatives will visit all identified hospitals and upgrade all systems to version 5.4.1. This will account for all consignees.
Quantity in Commerce 572
Distribution Worldwide Distribution.
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 = SURGICAL NAVIGATION TECHNOLOGIES, INC.
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