Recall Z-2707-2020 ยท HAW Neurological Stereotaxic Instrument
Medtronic Navigation, Inc.
StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures.
| Date | Jun 5, 2020 |
| Status | Terminated |
| Reason | There is a potential for specific camera units to be affected by a characterization issue during manufacturing that results in inaccurate navigation while utilizing both the active and passive trackers simultaneously. While no injuries or illnesses have been reported, If impacted cameras were to be used with both active and passive trackers simultaneously, it would result in system navigation inaccuracy of 6mm. |
| Root cause | Nonconforming Material/Component |
| Action | Urgent Medical Device Correction Letters were emailed to customers on June 5, 2020. Emails were followed by Medtronic representatives hand-delivering the recall notification letter as well as the customer confirmation form to the two affected consignees on June 12, 2020. Customers were informed that there is a potential for specific camera units to be affected by a characterization issue during manufacturing that results in inaccurate navigation while utilizing both the active and passive trackers simultaneously. Customers were informed that their local Medtronic representative would work wi |
| Quantity | 2 |
| Distribution | US Nationwide distribution including in the states of Alabama and Massachusetts. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133444 | STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM Medtronic Navigation, Inc., Jul 25, 2014 |