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.

Recall number

Z-2707-2020

Recalling firm

Medtronic Navigation, Inc.

Product

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.

Status

Terminated

Initiated

2020-06-05

Posted

not on file

Terminated

2024-05-28

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 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 rs.navtechsupport@medtronic.com 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.

Quantity

2

Distribution

US Nationwide distribution including in the states of Alabama and Massachusetts.

Lot, serial or model codes

StealthStation S7 Serial Number N06164844 with Polaris Spectra Camera Serial Number P7-01896; and StealthStation S7 Serial Number N07308697 with Polaris Spectra Camera Serial Number P7-18852.

510(k) numbers

["K133444"]

PMA numbers

not on file

Product code

HAW

Firm FEI

1000517638

Firm city

Louisville

Firm state

CO

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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