Recall Z-2129-2016 ยท LNH System, Nuclear Magnetic Resonance Imaging
Medtronic Navigation
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.
| Date | Jul 6, 2016 (initiated Jun 20, 2016) |
| Status | Terminated |
| Reason | 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. |
| 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 | 52 |
| Distribution | Worldwide Distribution - US Nationwide. |
| FDA record | Open on fda.gov |