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.
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.
The camera units may have a manufacturing issue that causes navigation inaccuracies of up to 6mm when both active and passive trackers are used together. This could lead to minor positioning errors during surgical procedures, but no injuries have been reported.
Medical professionals using the StealthStation S7 system with Polaris Spectra cameras for surgical procedures are most at risk. Patients receiving these procedures may also be affected if the system is used incorrectly.
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.
Identify the Polaris Spectra Camera part number (PSU 9733437) and serial numbers (N06164844 or N07308697) to confirm if your device is affected.
The recall indicates a potential for navigation inaccuracies of 6mm when using both trackers together, but no injuries have been reported. This is considered low risk.
Check for the Polaris Spectra Camera part number PSU 9733437 and the specific serial numbers N06164844 or N07308697 on your StealthStation S7 system.
The recall does not specify a remedy, so you should check with Medtronic directly to determine if a fix or alternative is available.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2707-2020 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2707-2020 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
