CLASS II Device recall · Reported 10 Aug 2016 · FDA Enforcement Report

MACH AxiEM Cranial Treon recalled by Medtronic Navigation

Medtronic Navigation is recalling MACH AxiEM Cranial Treon, distributed nationwide in the US. The recall was initiated on 18 Jul 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number 9730889. All lot numbers manufactured by Medtronic Navigation are affected.
Quantity recalled27 in total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-2319-2016
FDA event ID
74715
Recalling firm
Medtronic Navigation, Louisville, CO
Classification
Class II
Status
Terminated
Recall initiated
18 Jul 2016
FDA classified
2 Aug 2016
Reported
10 Aug 2016
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Device Malfunction

Timeline

18 Jul 2016Recall initiated by company
2 Aug 2016Classified by FDA+15 days
10 Aug 2016Published in enforcement report+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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 bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

Where it was distributed

Worldwide Distribution - US Nationwide in the state of: NY, AZ, AR, NC, CA, OH, MI, IN, MA, TX, OH, OR, CO, MO, UT, IL. and the countries of: India, Australia, and Russian Federation.

Nationwide ArkansasArizonaCaliforniaColoradoIllinoisIndianaMassachusettsMichiganMissouriNorth CarolinaNew YorkOhioOregonTexasUtah

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

Worldwide Distribution - US Nationwide in the state of: NY, AZ, AR, NC, CA, OH, MI, IN, MA, TX, OH, OR, CO, MO, UT, IL. and the countries of: India, Australia, and Russian Federation.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

6 other products · FDA event 74715

This product is part of a recall event; the main page for the event is S7 MACH FrameLink recalled by Medtronic Navigation.

ReportedClassRecallCompanyReasonWhere
CLASS IIS7 MACH FrameLink recalled by Medtronic NavigationMedtronic NavigationDevice MalfunctionNationwide
CLASS IIFrameLink. recalled by Medtronic NavigationMedtronic NavigationDevice MalfunctionNationwide
CLASS IISynergy Cranial S7 recalled by Medtronic NavigationMedtronic NavigationDevice MalfunctionNationwide
CLASS IIFusion ENT Application recalled by Medtronic NavigationMedtronic NavigationDevice MalfunctionNationwide
CLASS IISynergy Spine recalled by Medtronic NavigationMedtronic NavigationDevice MalfunctionNationwide
CLASS IIMACH Cranial Treon recalled by Medtronic NavigationMedtronic NavigationDevice MalfunctionNationwide

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All 92
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