Recall Z-1558-2011 ยท HAW Neurological Stereotaxic Instrument
Medtronic Navigation, Inc
Polaris Spectra Position Sensor Unit, a component of the StealthStation S7 System, Medtronic Navigation, Louisville, CO 80027. The Polaris Spectra Position Sensor Unit (PSU) is the component of the StealthStation S7 System which detects optical markers on instruments and reference frames, determines their spatial positions, and continuously reports this information to the system computer. The com
| Date | Mar 4, 2011 (initiated Dec 22, 2010) |
| Status | Terminated |
| Reason | Position Sensor Unit may generate tracking errors or may stop tracking immediately. |
| Root cause | Component design/selection |
| Action | The firm, Medtronic, sent a "Product Correction Notification" letter dated December 22, 2010, to all US Consignees/Customers on December 23, 2010 and foreign Consignees/Customers on December 27, 2010. The letter described the product, problem and actions to be taken. The customer were instructed to discontinue use of the impacted navigation system(s) until a replacement camera (PSU) is installed. A Medtronic Navigation Representative will visit each facility to remove the navigation camera and install a replacement. If you have any questions, contact your Medtronic Navigation Representativ |
| Quantity | 11 (US), 8 (Intnl) |
| Distribution | Worldwide distribution: USA including states of: CA, CO, GA, SC, TN, and WI; and countries including: Australia, Canada, Chile, Russia, Saudi Arabia, and South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050438 | STEALTHSTATION SYSTEM UPDATE Medtronic Surgical Navigation Technologies, Jun 2, 2005 |