Medtronic Navigation recalls PoleStar system (N20 / N30) Warning Lamps Control Box, Warning Lamps Control Box Cables, Thermoflex Chiller Product The…

Recall date

June 20, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2129-2016

FDA classification

Class II

Brand / firm

Medtronic Navigation

Sold / distributed

Worldwide Distribution - US Nationwide.

Why it was recalled

Medtronic Navigation is recalling certain components of the PoleStar system (N20 / N30) because of misplaced ground pins which may cause electrical shock to the user.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

PoleStar system (N20 / N30) Warning Lamps Control Box, Warning Lamps Control Box Cables, Thermoflex Chiller Product The PoleStar Surgical MRI System is intended for use as an intraoperative imaging device to produce MRI images of sections of the head selected by the physician.