Medtronic StealthStation S7 System
FDA Recall Z-2029-2010 · Posted 2010-07-17
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Recalling FirmMedtronic Navigation, Inc
Recall StatusTerminated
Product CodeHAW
Date Initiated2010-06-14
Date Terminated2011-02-18
Product Quantity370 units
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.
Firm Action
Customers 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.
Root Cause
Device Design
Distribution Pattern
Nationwide, 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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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