Z-2129-2016Class II

PoleStar system (N20 / N30) Warning Lamps Control Box, Warning Lamps Control Box Cables, Thermoflex Chiller...

Name: Z-2129-2016 PoleStar system (N20 / N30) Warning Lamps Control Box, Warning Lamps Control Box Cables, Thermoflex Chiller...
Creator: Medtronic Navigation
Published: 2016-06-20
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2016-06-20 / Terminated

FDA source

Medtronic Navigation began a recall of PoleStar system (N20 / N30) Warning Lamps Control Box, Warning Lamps Control Box Cables, Thermoflex Chiller Product The PoleStar Surgical MRI System is... on 2016-06-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2129-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-20
Posted: 2016-07-06
Terminated: 2017-06-21
Recalling firm: Medtronic Navigation, Inc
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.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
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 root cause: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2129-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2129-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-13	2016-07-06

Product code LNH

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)