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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic StealthStation S7 System

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 Class 2 Device Recall Medtronic StealthStation S7 Systemsee related information
Date Initiated by FirmJune 14, 2010
Date PostedJuly 17, 2010
Recall Status1 Terminated 3 on February 18, 2011
Recall NumberZ-2029-2010
Recall Event ID 56013
510(K)NumberK050438 
Product Classification Neurological stereotaxic instrument - Product Code HAW
ProductMedtronic StealthStation S7 System
Code Information All lots.
FEI Number 1000517638
Recalling Firm/
Manufacturer		 Medtronic Navigation, Inc
826 Coal Creek Circle
Louisville CO 80027-9710
For Additional Information Contact
720-890-3409
Manufacturer Reason
for Recall		Excessive wear at the power cord retractor or incorrect assembly of the power plug may cause sparking, intermittent loss of power, or electrical shock.
FDA Determined
Cause 2		Device Design
ActionCustomers were notified by letter on Jun 14, 2010, advising them of the problem. Instructions were provided to continue using existing retractable power cords until they could be replaced with non-retractable cords by Medtronic, beginning on Aug 17. Further information is available from the company by calling 800-595-9709.
Quantity in Commerce370 units
DistributionNationwide, including 3 VA facilities. No military distribution. Foreign accounts in Australia, Austria, Belgium, Canada, Chile, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Italy, Latvia, Libya, Lithuania, Luxembourg, Malaysia, Namibia, Netherlands, New Zealand, Poland, Puerto Rico, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, United Arab Emirates.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HAW
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