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Recall Observatory FDA recall evidence

Device 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.

Z-2129-2016

June 20, 2016

Class II

Product summary

Firm
Medtronic Navigation
Event
Event 74464
Status
Terminated
Classification
Class II
Quantity
52
Official record key
device-enforcement:Z-2129-2016

Official wording

Reason: 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.

Code information: Model No. 506A0107-01 & 506A0107-02 - Warning Lamps Control Box; 504A0276-01, 504A0277-01& 504A0278-01 - Warning Lamps Control Box Cables; 506A0297-01 & 506A0298-01 - Thermoflex Chiller

Distribution pattern: Worldwide Distribution - US Nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.