PoleStar system — Class II medical device recall Z-2129-2016
Terminated recall by Medtronic Navigation, reported 2016-07-13, distributed nationwide. Medtronic Navigation is recalling certain components of the PoleStar system (N20 / N30) because of misplaced g
| Recall number | Z-2129-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Navigation, Yokne'am Ilit, N/A, Israel |
| Recall initiated | 2016-06-20 |
| Classified | 2016-07-06 |
| Reported by FDA | 2016-07-13 |
| Terminated | 2017-06-21 |
| Distributed | Nationwide (US) |
| Quantity | 52 |
| Model numbers | 506A0107-01, 506A0107-02 |
Product
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2129-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.