Recall Z-2029-2010 ยท HAW Neurological Stereotaxic Instrument
Medtronic Navigation, Inc
Medtronic StealthStation S7 System
| Date | Jul 17, 2010 (initiated Jun 14, 2010) |
| Status | Terminated |
| Reason | Excessive wear at the power cord retractor or incorrect assembly of the power plug may cause sparking, intermittent loss of power, or electrical shock. |
| Root cause | Device Design |
| 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. |
| Quantity | 370 units |
| Distribution | 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, Nam |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050438 | STEALTHSTATION SYSTEM UPDATE Medtronic Surgical Navigation Technologies, Jun 2, 2005 |