—#97017

Product

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 computer uses this spatial information, in conjunction with information regarding the geometry of the instrument currently in use, to determine where the tip of the instrument is located on the patient anatomy.

FDA product code: HAW — Neurological Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K050438
Affected lot / code info: Serial Numbers: P703048, P703049, P703050, P703054, P703055, P703060, P703061, P703063, P703066, P703068, P703070, P703076, P703077, P703079, P703114, P703140, P703141, P703143.

Why it was recalled

Position Sensor Unit may generate tracking errors or may stop tracking immediately.

Root cause (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm: Medtronic Navigation, Inc
Address: 826 Coal Creek Circle, Louisville, Colorado 80027-9710

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2010-12-22
Posted by FDA: 2011-03-04
Terminated: 2011-03-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #97017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.