Medtronic StealthStation S7 System
FDA device recall Z-2029-2010 · posted 2010-07-17 · Terminated
Recall details
- Recalling firm
- Medtronic Navigation, Inc
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- HAW
- Quantity affected
- 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
- Date initiated
- 2010-06-14
- Date posted
- 2010-07-17
- Date terminated
- 2011-02-18
- Location
- Louisville, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STEALTHSTATION SYSTEM UPDATE (K050438) | Medtronic Surgical Navigation Technologies | 2005-06-02 |