Medtronic recalls Stealth S8 Clinical Software versions 1.0.1-1.2.0 for potential missing digits in navigation displays during neurosurgery. Affected units may cause navigation errors.
Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation.
Medtronic is recalling its Stealth S8 Clinical Software Application versions 1.0.1 through 1.2.0. This software, used with the StealthStation System for neurosurgery, could show missing digits or letters in navigation displays, potentially causing navigation errors during procedures.
The software may display missing digits, letters, or decimals in the 'distance to target' or 'tip stop point' navigation fields. This could lead to navigation errors during neurosurgical procedures if the missing information is not noticed.
Neurosurgeons using the Stealth S8 Clinical Software Application with StealthStation System for neurosurgery procedures. The risk is highest for those using specific software versions.
Check for software versions 1.0.1 through 1.2.0 on the Stealth S8 Clinical Software Application. The product is used with the StealthStation System for neurosurgery procedures and has specific UDIs: 00763000234867, 00763000125295, 00763000063177, 00643169865341.
Verify the software version on your Stealth S8 Clinical Software Application to see if it is affected (1.0.1 through 1.2.0).
No, this software is used specifically in neurosurgical procedures with the StealthStation System.
Software versions 1.0.1 through 1.2.0.
Check for UDIs: 00763000234867, 00763000125295, 00763000063177, 00643169865341, or software versions 1.0.1 through 1.2.0.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1776-2024 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1776-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
