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Medtronic Navigation recalls PoleStar system (N20 / N30) Warning Lamps Control Box, Warning Lamps Control Box Cables, Thermoflex Chiller Product T
Recalled July 13, 2016 · FDA recall Z-2129-2016 · Medtronic Navigation
Hazard
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. · FDA Class II
Units
52
Sold at
Worldwide Distribution - US Nationwide.
Description
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.
Product
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.
Manufacturer(s)
Medtronic Navigation
Made in
Israel
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →