Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2129-2016 — 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.

U.S. FDA — Device Enforcement · Israel · 2016-06-20 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2129-2016
Date of alert: 2016-06-20
Country / jurisdiction: Israel
Risk level: Class II
Risk type: recall
Brand: Medtronic Navigation
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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