Recall Z-2129-2016— Medtronic Navigation

Name: FDA recall Z-2129-2016
Creator: U.S. Food and Drug Administration
Published: 2016-06-20

Class II · Terminated

Class II FDA medical device recall by Medtronic Navigation, initiated 2016-06-20, terminated 2017-06-21. It names 2 FDA 510(k) clearances: K092308, K032541. 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.. 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..

Recalling firm: Medtronic Navigation
Classification: Class II
Status: Terminated
Initiated: 2016-06-20
Terminated: 2017-06-21
Firm location: Yokne'am Ilit, N/A, Israel

510(k) clearances named in this recall

2 on FDA's record

K092308 — POLESTAR, MODEL N-30Medtronic Navigation Israel, Ltd.·cleared 2010-03-16
K032541 — POLESTAR N-20Odin Medical Technologies , Ltd.·cleared 2003-09-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.