Medtronic recalls StealthStation S8 App versions 1.3.0 and 1.3.2 (Model # 9735762) due to two software anomalies that can cause images to appear flipped or fail to display warnings during spine procedures.
Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, information may appear flipped when utilizing the system (180 degree flipped). 2. Pop-up Message - when using CT+Fluouroscopy images with a slice spacing thickness greater than 2mm, the system does not display a pop-up message indicating the slice spacing is not optimal.
Medtronic is recalling specific versions of its StealthStation S8 App software (1.3.0 and 1.3.2) because they have two software issues that could cause images to appear flipped or fail to show warnings during spine procedures. This may affect surgical precision and safety.
The software has two issues: 1) During lateral orientation radiographic images, information may appear flipped (180 degrees) when using the system. 2) When using CT+Fluoroscopy images with slice spacing greater than 2mm, the system doesn't display a warning message indicating the slice spacing is not optimal. These issues could lead to less precise surgical procedures.
Medical professionals using the StealthStation S8 App software with the specified model numbers for spine procedures. The risk is low as these are software issues that don't cause immediate harm but could affect surgical accuracy.
Check if your StealthStation S8 App is version 1.3.0 or 1.3.2 with the model number 9735762. The product includes specific serial numbers listed in the recall notice.
Verify your StealthStation S8 App version is 1.3.0 or 1.3.2 with model number 9735762.
StealthStation S8 App versions 1.3.0 and 1.3.2 with model number 9735762.
Two issues: 1) Navigation Orientation - images may appear flipped (180 degrees) during lateral orientation radiographic images. 2) Pop-up Message - the system doesn't display a warning when using CT+Fluoroscopy images with slice spacing greater than 2mm.
Check your software version. If affected, contact Medtronic for updates or corrections.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0050-2025 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0050-2025 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.
