FDA Enforcement
Class II
Terminated
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.
Recall: Z-2129-2016
·
Reported July 13, 2016
Enforcement
- Recall Number
- Z-2129-2016
- Event ID
- 74464
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Medtronic Navigation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 13, 2016
- Initiation Date
- June 20, 2016
- Classification Date
- July 6, 2016
- Termination Date
- June 21, 2017
- Address
- Kochav Yokneam, 1 Hamelacha St., Yokne'am Ilit, N/A, N/A, Israel
Description
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.
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.
Code Info
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
Worldwide Distribution - US Nationwide.
Quantity
52