The Recall Desk
HighFDA (Devices)·Z-0050-2025·Announced 2024-10-16

StealthStation S8 Spine Surgery Navigation System Recalled for Software Defects

Medtronic is recalling 1,801 StealthStation S8 surgical navigation systems due to software anomalies that can flip navigation images during spine surgery and prevent warning messages for suboptimal imaging settings.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm product (surgical navigation system) where potential injury has not yet been reported, which matches the Score 3 (High) criterion. The FDA Class II classification without reported hospitalizations supports this high-severity classification.

Plain-English summary

The FDA has issued a Class II recall of 1,801 Medtronic StealthStation S8 App surgical navigation systems (Model 9735762, versions 1.3.0 and 1.3.2). These systems are used during neurosurgical and orthopedic spine procedures to help surgeons precisely locate anatomical structures during open or minimally invasive surgery.

Two software anomalies have been identified in the affected systems. The first issue causes navigation images to appear flipped (rotated 180 degrees) when lateral orientation radiographic images are used during a spine procedure, potentially misleading the surgeon about anatomical location. The second issue occurs when using combined CT and fluoroscopy images with slice spacing greater than 2 millimeters: the system fails to display a warning message indicating that the slice spacing is not optimal for surgical navigation.

The affected systems have been distributed worldwide, including throughout the United States and Puerto Rico, as well as to numerous countries internationally.

Healthcare providers using StealthStation S8 systems should verify whether their systems are affected using the provided serial number list and contact Medtronic Navigation, Inc. for instructions on how to address this issue.

The recalled product

Product
StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures.
Manufacturer
Medtronic Navigation, Inc.
Category
Medical Device — Surgical Navigation System
Hazard
  • image-orientation-error
  • missing-warning-message
  • software-anomaly

Distribution

Distributed nationwide across the United States.

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