FDA-Device2016-07-13Class II
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.
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.
Sold states
Worldwide Distribution - US Nationwide.
Affected count
52
Manufactured in
Kochav Yokneam, 1 Hamelacha St., Yokne'am Ilit, N/A, Israel
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2129-2016Don't want to check this manually?
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