Z-2707-2020Class II

StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 -

Name: Z-2707-2020 StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 -
Creator: Medtronic Navigation, Inc.
Published: 2020-06-05
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2020-06-05 / Terminated / root cause: manufacturing process

FDA source

Medtronic Navigation, Inc. began a recall of StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are intended as an aid for precisely locating anatomical... on 2020-06-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2707-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-05
Posted: 2020-07-27
Terminated: 2024-05-28
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.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: 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 tag: manufacturing process
FDA 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 [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.
Quantity in commerce: 2
Distribution: US Nationwide distribution including in the states of Alabama and Massachusetts.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2707-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2707-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-05	2020-07-27

Product code HAW

K133444Class IIStealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation SystemMedtronic Navigation, Inc. / cleared 2014-07-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)