FDAFDA · Food and drugs·Recall number Z-2129-2016
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.
Published July 13, 2016 · Recall initiated: June 20, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Navigation
- Distributor
- Worldwide Distribution - US Nationwide.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Israel
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