Medtronic PoleStar MRI System Components Recalled for Electrical Shock Risk
Medtronic Navigation is recalling PoleStar MRI system components due to misplaced ground pins that may cause electrical shock to users.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (electrical shock) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Medtronic Navigation is recalling specific components of the PoleStar system (N20 / N30) Surgical MRI System. The affected parts include the Warning Lamps Control Box, Warning Lamps Control Box Cables, and Thermoflex Chiller. The recall is being conducted because of misplaced ground pins which may cause electrical shock to the user.
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. The recall covers 52 units distributed worldwide and nationwide in the US. Specific model numbers affected include 506A0107-01 & 506A0107-02 for the Warning Lamps Control Box; 504A0276-01, 504A0277-01 & 504A0278-01 for the Warning Lamps Control Box Cables; and 506A0297-01 & 506A0298-01 for the Thermoflex Chiller.
Healthcare facilities and users should check their inventory for these specific model numbers. If the affected components are present, they should contact Medtronic Navigation for instructions on how to resolve the issue.
The recalled product
- 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…
- Manufacturer
- Medtronic Navigation
- Hazard
- Affected units
- 52
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 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
Distributed nationwide across the United States.
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