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.

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.

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 with them to remove and replace the affected camera on your impacted system. Customers were informed that Medtronic has not identified any complaints or reports of injury related to this issue. However, if impacted cameras were to be used with both active and passive trackers simultaneously, it would result in system navigation inaccuracy of 6mm. Customers were requested to not use the affected StealthStation" S7 System unit for simultaneous active and passive navigation (such as active instrumentation, active reference frames, or a navigated microscope) until the camera is replaced on this system; to work with their Medtronic representative to replace the camera on their impacted system; and to sign and return the enclosed customer confirmation form, acknowledging receipt of this information.Customers were notified that Medtronic is communicating this information to the Food and Drug Administration (FDA). Adverse events or quality problems experienced with this product should be reported to FDA and Medtronic: Online at the FDA website (www.fda.gov) or call FDA at 1-800-FDA-1088 and via E-mail to Medtronic at [email protected] or by calling 1-888-826-5603. Customers with any questions regarding the urgent medical device correction should contact Medtronic Technical Services at 1-888-826-5603.