The Recall Desk

Hazard

Navigation Inaccuracy recalls

6 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
6
Critical
0
Severe
0
Most recent
2024-05-29

Of the 6 navigation inaccuracy recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all navigation inaccuracy recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–6 of 6

  • HighFDA (Devices)·Z-1885-2024·2024-05-29

    Scopis ENT Navigation Software Contains Visual Guidance Alignment Error

    Unreleased software in Scopis ENT surgical navigation systems causes visual guidance to display inaccurately relative to physical reference points, affecting surgical precision. Affects 705 units nationwide.

    Product
    8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for navigating functional endoscopic sinus surgery (FESS) offering surgeons highly advanced image guidance and visualization capabilities in a single system. T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0417-2022·2021-12-29

    Surgical Navigation Tracker Subject to Weld Failure and Navigation Inaccuracy

    A surgical navigation tracker used in neurosurgery may experience weld failure, leading to navigation inaccuracy, prolonged procedure time, and potential tissue injury. 98 affected units were distributed across US and international healthcare facilities.

    Product
    Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: 9736188, and the Bundle Autoguide Reg Kit.
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-2707-2020·2020-08-05

    Medtronic StealthStation S7 System Recalled for Navigation Inaccuracy

    Medtronic is recalling two StealthStation S7 Systems with Polaris Spectra Cameras due to a manufacturing issue that may cause 6mm navigation inaccuracy when using specific trackers.

    Product
    StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1007-2017·2017-01-18

    Medtronic Recalls AxIEM Touch N Go Pointer Probe for Accuracy Issues

    Medtronic Navigation is voluntarily recalling 111 AxIEM Touch N Go Pointer Probes because they may compromise navigation accuracy during patient registration.

    Product
    AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG tray sealed with a Tyvek lid and then placed in a shelf carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2065-2012·2012-08-01

    GE OEC 8800 Flexview X-ray System Recalled for Safety Issues

    GE OEC Medical Systems is recalling OEC 8800 Flexview x-ray systems due to intermittent safety issues including navigation tracking inaccuracy and system lock-up.

    Product
    OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system Product Usage: The 8800 Flexview is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical applications may include c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1865-2012·2012-07-04

    GE OEC Uroview 2800 Recalled for Intermittent Safety Issues

    GE OEC Medical Systems is recalling 717 OEC Uroview 2800 fluoroscopic imaging systems due to intermittent safety issues, including navigation tracking inaccuracy and system lock-ups.

    Product
    OEC Uroview 2800, Model number A349855. Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures.
    Category
    Medical Device
    Distribution
    0 states