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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 FirmJune 20, 2016
Date PostedJuly 06, 2016
Recall Status1 Terminated 3 on June 21, 2017
Recall NumberZ-2129-2016
Recall Event ID 74464
510(K)NumberK032541 K092308 
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
ProductPoleStar 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/
Manufacturer		 Medtronic Navigation
Kochav Yokneam
1 Hamelacha St.
Yokne'am Ilit Israel
For Additional Information ContactTom Reimann
720-890-3241
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
ActionMedtronic 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 Commerce52
DistributionWorldwide Distribution - US Nationwide.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LNH
510(K)s with Product Code = LNH
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