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Terminated

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.

FDA Recall Z-2129-2016 · Posted 2016-07-06

Recalling FirmMedtronic Navigation
Recall StatusTerminated
Product CodeLNH
Date Initiated2016-06-20
Date Terminated2017-06-21
Product Quantity52

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.

Firm Action

Medtronic sent a Field Safety Notice letter dated August 1, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were informed that Medtronic will perform an inspection on site to verify and correct the grounding connection of the PoleStar System. For questions contact Medtronic Navigation Technical Services at 1-800-595-9709.

Root Cause

Process change control

Distribution Pattern

Worldwide Distribution - US Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K092308POLESTAR, MODEL N-30Medtronic Navigation Israel, Ltd. · 2010-03-16K032541POLESTAR N-20Odin Medical Technologies , Ltd. · 2003-09-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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