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U.S. Department of Health and Human Services

Class 2 Device Recall Stereotaxic Navigation System

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  Class 2 Device Recall Stereotaxic Navigation System see related information
Date Initiated by Firm January 28, 2005
Date Posted April 16, 2005
Recall Status1 Terminated 3 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 2
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 and Original Applicant = SURGICAL NAVIGATION TECHNOLOGIES, INC.
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