Medtronic recalls StealthStation S8 software versions 2.0 and 2.0.1 due to potential surgical planning data shifting. Affected units may require software update or replacement to prevent errors in neurosurgery or ENT procedures.
Due to a software anomaly which potentially could result in the surgical planning data shifting to an unintended location.
Medtronic is recalling StealthStation S8 software versions 2.0 and 2.0.1 because a software issue could cause surgical planning data to shift unexpectedly. This might lead to errors during neurosurgery or ENT procedures if the software is used without correction.
A software anomaly in versions 2.0 and 2.0.1 could cause surgical planning data to shift to an unintended location. This might lead to incorrect anatomical structures being identified during procedures, potentially causing errors in neurosurgery or ENT surgeries.
Surgical teams using Medtronic StealthStation S8 systems with software versions 2.0 or 2.0.1 are affected. Neurosurgeons and ENT specialists using the system for procedures are most at risk.
Check if your StealthStation S8 system has software version 2.0 or 2.0.1. The model number is 9735762, and the system was sold with the UDI-DI code 00763000532123.
Verify your StealthStation S8 system's software version by checking the model number and UDI-DI code.
The recall is for software versions 2.0 and 2.0.1. If your system has these versions, you may need to update or replace the software to prevent errors during procedures.
Check your StealthStation S8 system's model number (9735762) and software version. The UDI-DI code 00763000532123 identifies the affected units.
The recall does not specify a remedy, so contact Medtronic directly to discuss software updates or replacements.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0188-2024 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0188-2024 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.
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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.
