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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic PoleStar Intraoperative MRI system (N20 / N30)

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  Class 2 Device Recall Medtronic PoleStar Intraoperative MRI system (N20 / N30) see related information
Date Initiated by Firm June 20, 2016
Date Posted July 06, 2016
Recall Status1 Terminated 3 on June 21, 2017
Recall Number Z-2129-2016
Recall Event ID 74464
510(K)Number K032541  K092308  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
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.
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
Recalling Firm/
Medtronic Navigation
Kochav Yokneam
1 Hamelacha St.
Yokne'am Ilit Israel
For Additional Information Contact Tom Reimann
Manufacturer 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.
FDA Determined
Cause 2
Process change control
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.
Quantity in Commerce 52
Distribution Worldwide Distribution - US Nationwide.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = MEDTRONIC NAVIGATION ISRAEL, LTD.
510(K)s with Product Code = LNH and Original Applicant = ODIN MEDICAL TECHNOLOGIES LTD.