Polaris Spectra Position Sensor Unit, a component of the StealthStation S7 System, Medtronic Navigation, Louisville, CO
FDA device recall Z-1558-2011 · posted 2011-03-04 · Terminated
Recall details
- Recalling firm
- Medtronic Navigation, Inc
- Reason for recall
- Position Sensor Unit may generate tracking errors or may stop tracking immediately.
- Action taken
- 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 Representative or Medtronic Navigation Technical Support services at 1-800-595-9709 or +1-720-890-3200.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- HAW
- Quantity affected
- 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.
- Date initiated
- 2010-12-22
- Date posted
- 2011-03-04
- Date terminated
- 2011-03-11
- 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 |