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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74464

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
June 20, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Medtronic Navigation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2129-2016
Recall number
Z-2129-2016
Initiated
June 20, 2016
Classification
Class II
Status
Terminated
Recalling firm
Medtronic Navigation
Quantity
52

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

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.

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

Distribution pattern

Worldwide Distribution - US Nationwide.