Z-1558-2011

Polaris Spectra Position Sensor Unit, a component of the StealthStation S7 System, Medtronic Navigation...

Name: Z-1558-2011 Polaris Spectra Position Sensor Unit, a component of the StealthStation S7 System, Medtronic Navigation...
Creator: Medtronic Navigation, Inc
Published: 2010-12-22
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2010-12-22 / Terminated / root cause: design

FDA source

Medtronic Navigation, Inc began a recall of Polaris Spectra Position Sensor Unit, a component of the StealthStation S7 System, Medtronic Navigation, Louisville, CO 80027. The Polaris Spectra Position... on 2010-12-22. The reason FDA records is "Position Sensor Unit may generate tracking errors or may stop tracking immediately". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1558-2011
Status: Terminated
Initiated: 2010-12-22
Posted: 2011-03-04
Terminated: 2011-03-11
Recalling firm: Medtronic Navigation, Inc
Product: Polaris Spectra Position Sensor Unit, a component of the StealthStation S7 System, Medtronic Navigation, Louisville, CO 80027. The Polaris Spectra Position Sensor Unit (PSU) is the component of the StealthStation S7 System which detects optical markers on instruments and reference frames, determines their spatial positions, and continuously reports this information to the system computer. The computer uses this spatial information, in conjunction with information regarding the geometry of the instrument currently in use, to determine where the tip of the instrument is located on the patient anatomy.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: Position Sensor Unit may generate tracking errors or may stop tracking immediately.
Root cause tag: design
FDA root cause: Component design/selection
Action: The firm, Medtronic, sent a "Product Correction Notification" letter dated December 22, 2010, to all US Consignees/Customers on December 23, 2010 and foreign Consignees/Customers on December 27, 2010. The letter described the product, problem and actions to be taken. The customer were instructed to discontinue use of the impacted navigation system(s) until a replacement camera (PSU) is installed. A Medtronic Navigation Representative will visit each facility to remove the navigation camera and install a replacement. If you have any questions, contact your Medtronic Navigation Representative or Medtronic Navigation Technical Support services at 1-800-595-9709 or +1-720-890-3200.
Quantity in commerce: 11 (US), 8 (Intnl)
Distribution: Worldwide distribution: USA including states of: CA, CO, GA, SC, TN, and WI; and countries including: Australia, Canada, Chile, Russia, Saudi Arabia, and South Africa.
Product codes and lots: Serial Numbers: P703048, P703049, P703050, P703054, P703055, P703060, P703061, P703063, P703066, P703068, P703070, P703076, P703077, P703079, P703114, P703140, P703141, P703143.

Product code HAW

K050438Class IIStealthstation System UpdateMedtronic Surgical Navigation Technologies / cleared 2005-06-02

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)