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

Agency Publication Date: August 2, 2016

Affected Products

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 procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod,

Model Number 9733763. All lot numbers manufactured by Medtronic Navigation are affected.

Lot Numbers:

numbers

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. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or verteb

Model Number 9733986-02 . All lot numbers manufactured by Medtronic Navigation are affected.

Lot Numbers:

numbers

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 procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, o

Model Number 9733986 . All lot numbers manufactured by Medtronic Navigation are affected.

Lot Numbers:

numbers

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 procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or ver

Model Number 9733686-02. All lot numbers manufactured by Medtronic Navigation are affected.

Lot Numbers:

numbers

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 percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long b

Model Number 9733467. All lot numbers manufactured by Medtronic Navigation are affected.

Lot Numbers:

numbers

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 procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod,

Model Number 9730888. All lot numbers manufactured by Medtronic Navigation are affected.

Lot Numbers:

numbers

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 percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long

Model Number 9730889. All lot numbers manufactured by Medtronic Navigation are affected.

Lot Numbers:

numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 74715

Status: Resolved

Manufacturer: Medtronic Navigation, Inc.

Manufactured In: United States

Units Affected: 7 products (27 in total)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Model Number 9733763. All lot numbers manufactured by Medtronic Navigation are affected.

Lot Numbers:

numbers

Model Number 9733986-02 . All lot numbers manufactured by Medtronic Navigation are affected.

Lot Numbers:

numbers

Model Number 9733986 . All lot numbers manufactured by Medtronic Navigation are affected.

Lot Numbers:

numbers

Model Number 9733686-02. All lot numbers manufactured by Medtronic Navigation are affected.

Lot Numbers:

numbers

Model Number 9733467. All lot numbers manufactured by Medtronic Navigation are affected.

Lot Numbers:

numbers

Model Number 9730888. All lot numbers manufactured by Medtronic Navigation are affected.

Lot Numbers:

numbers

Model Number 9730889. All lot numbers manufactured by Medtronic Navigation are affected.

Lot Numbers:

numbers