Medtronic Navigation: Medical Device Recall in 2016 - (Recall #: Z-2129-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 20, 2016

Date Posted: July 13, 2016

Recall Number: Z-2129-2016

Event ID: 74464

Reason for Recall:

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.

Status: Terminated

Product Quantity: 52

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.

Voluntary or Mandated:

Voluntary: Firm initiated