Recalls / —

—#92424

Product

Medtronic StealthStation S7 System

FDA product code

HAW — Neurological Stereotaxic Instrument

Device class

Class 2

Medical specialty

Neurology

510(k) numbers

K050438

Affected lot / code info

All lots.

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm

Medtronic Navigation, Inc

Address

826 Coal Creek Circle, Louisville, Colorado 80027-9710

Distribution

Distribution pattern

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, Namibia, Netherlands, New Zealand, Poland, Puerto Rico, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, United Arab Emirates.

Timeline

Recall initiated

2010-06-14

Posted by FDA

2010-07-17

Terminated

2011-02-18

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #92424. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.