Lower riskMedical device recall · FDA · Published June 5, 2020
Medtronic StealthStation S7 Camera Recall: Inaccurate Navigation When Using Both Trackers
Medtronic recalls StealthStation S7 System with Polaris Spectra Camera (PSU 9733437) due to potential navigation inaccuracies of 6mm when using both active and passive trackers simultaneously. No injuries reported.
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.
Take action
Contact the company
📍Recalling firmMedtronic Navigation, Inc.826 Coal Creek Cir · Louisville, CO 80027-9710
✎ GovInfoNow plain-language explainer
Medtronic is recalling specific StealthStation S7 systems with Polaris Spectra cameras because they may give inaccurate navigation readings when used with both active and passive trackers at the same time. This could lead to positioning errors during medical procedures, though no injuries have been reported. Read more at govinfonow.com/recall/65027-medtronic-stealthstation-s7-camera-recall-inaccurate-navigation-when-using-both.
“Medtronic StealthStation S7 Camera Recall: Inaccurate Navigation When Using Both Trackers.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65027-medtronic-stealthstation-s7-camera-recall-inaccurate-navigation-when-using-both. Based on FDA recall #Z-2707-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2707-2020%22&limit=1).
The FDA announced on June 5, 2020, that Medtronic Navigation, Inc. is recalling two StealthStation S7 Systems with Polaris Spectra Cameras due to potential navigation inaccuracies. The agency classified the recall as Class II.
How to tell if you have it
StealthStation S7 System with Polaris Spectra Camera part number PSU 9733437
StealthStation S7 Serial Number N06164844 with Polaris Spectra Camera Serial Number P7-01896
StealthStation S7 Serial Number N07308697 with Polaris Spectra Camera Serial Number P7-18852
The hazard
According to the FDA, specific camera units may have a characterization issue resulting in inaccurate navigation when using both active and passive trackers simultaneously. If impacted cameras were used in this manner, it would result in system navigation inaccuracy of 6mm. No injuries or illnesses have been reported.
Context
GovInfoNow's records show Medtronic Navigation, Inc. has 25 other recalls on record since June 7, 2017. Recent brand recalls include PIN surgical pins that may not fit patient reference frames (Dec. 4, 2024), StealthStation S8 App software issues causing flipped images (Aug. 22, 2024), and missing digits during neurosurgery (March 26, 2024). Other recent recalls of similar products include GE Medical Systems Imactis CT-Navigation System Recall (Feb. 3, 2026) and Civco eTRAX Needle Sensor Recalls (March 2, 2026).
How to tell if you have this one
Check for the Polaris Spectra Camera part number PSU 9733437 on the device. The specific systems recalled include StealthStation S7 with serial numbers N06164844 and N07308697.
Brand
Medtronic
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Details
Identify the Polaris Spectra Camera part number (PSU 9733437) and serial numbers (N06164844 or N07308697) to confirm if your device is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution including in the states of Alabama and Massachusetts.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Massachusetts.
Recall timeline
FDA terminated this recall 4 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2707-2020 (June 5, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2707-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.