PoleStar system (N20 / N30) Warning Lamps Control Box, Warning Lamps Control Box Cables, Thermoflex Chiller Product The
FDA device recall Z-2129-2016 · posted 2016-07-06 · Terminated
Recall details
- Recalling firm
- Medtronic Navigation
- 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.
- Action taken
- 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.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 52
- Distribution
- Worldwide Distribution - US Nationwide.
- Date initiated
- 2016-06-20
- Date posted
- 2016-07-06
- Date terminated
- 2017-06-21
- Location
- Ilit, Israel
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| POLESTAR, MODEL N-30 (K092308) | Medtronic Navigation Israel, Ltd. | 2010-03-16 |
| POLESTAR N-20 (K032541) | Odin Medical Technologies , Ltd. | 2003-09-12 |