The Recall Desk

FDA (Devices) recall action 74715

Medtronic Navigation, Inc. recalled 7 products on 2016-08-10

The FDA (Devices) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.

Products
7
Announced
2016-08-10
Critical
0
Units
189

Why these products were recalled

Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–7 of 7

  • ModerateFDA (Devices)··2016-08-10

    Medtronic StealthStation Software Recalled Due to Scanner Compatibility Issues

    Medtronic Navigation is voluntarily recalling 27 units of StealthStation software due to compatibility issues with specific floor-based scanners.

    Product
    MACH AxiEM Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutan
    Category
    Distribution
    15 states
  • ModerateFDA (Devices)··2016-08-10

    Medtronic Navigation Recalls StealthStation Software Applications

    Medtronic Navigation is conducting a voluntary field action for StealthStation software applications affected by Neurologica BodyTom/CereTom floor-based scanners.

    Product
    FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures
    Category
    Distribution
    15 states
  • ModerateFDA (Devices)··2016-08-10

    Medtronic Navigation Recalls Fusion ENT Software Application

    Medtronic Navigation is voluntarily recalling 27 units of the Fusion ENT software application due to a field action involving Neurologica scanners.

    Product
    Fusion ENT Application. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneo
    Category
    Distribution
    15 states
  • ModerateFDA (Devices)··2016-08-10

    Medtronic Navigation Recalls S7 MACH FrameLink Software Applications

    Medtronic Navigation is conducting a voluntary field action for S7 MACH FrameLink software applications affected by Neurologica BodyTom/CereTom floor-based scanners.

    Product
    S7 MACH FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous pr
    Category
    Distribution
    15 states
  • ModerateFDA (Devices)··2016-08-10

    Medtronic Navigation Recalls Synergy Cranial S7 Software Applications

    Medtronic Navigation is conducting a voluntary field action for Synergy Cranial S7 software applications due to compatibility issues with specific floor-based scanners.

    Product
    Synergy Cranial S7. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous p
    Category
    Distribution
    15 states
  • ModerateFDA (Devices)··2016-08-10

    Medtronic Navigation StealthStation Software Voluntary Field Action

    Medtronic Navigation is conducting a voluntary field action for StealthStation software applications affected by Neurologica BodyTom/CereTom floor-based scanners.

    Product
    Synergy Spine. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedu
    Category
    Distribution
    15 states
  • ModerateFDA (Devices)··2016-08-10

    Medtronic Navigation Recalls StealthStation Software Applications

    Medtronic Navigation is voluntarily recalling StealthStation software applications affected by Neurologica BodyTom/CereTom floor-based scanners.

    Product
    MACH Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous p
    Category
    Distribution
    15 states