Reported Jul 13, 2016 · Terminated
PoleStar system (N20 / N30) Warning Lamps Control Box, Warning Lamps Control Box Cables, Thermoflex Chiller Product The…
Medtronic Navigation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Navigation · Kochav Yokneam · Yokne'am Ilit, N/A · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- 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
- Amount recalled
- 52
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Medtronic Navigation recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.