The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2319-2016·Announced 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is a voluntary field action for a software compatibility issue with specific scanners. No injuries, illnesses, or deaths are reported in the source text, and the hazard is theoretical or operational rather than a direct physical safety risk like a defect or contamination.

Plain-English summary

Medtronic Navigation, Inc. has announced a voluntary field action for the Medtronic Navigation StealthStation Software applications. This action affects software versions that are impacted by Neurologica BodyTom/CereTom floor-based scanners. The software is distributed in CD format with an instruction for use (IFU), wrapped in plastic with a shipping label.

The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is indicated for medical conditions where stereotactic surgery may be appropriate and where reference to a rigid anatomical structure, such as the skull, can be identified relative to imaging models or digitized landmarks. The recall involves 27 units in total, with Model Number 9730889. All lot numbers manufactured by Medtronic Navigation are affected.

The affected products were distributed worldwide, including nationwide in the United States across states such as NY, AZ, AR, NC, CA, OH, MI, IN, MA, TX, OR, CO, MO, UT, and IL, as well as in India, Australia, and the Russian Federation. Users of the affected software should contact Medtronic Navigation for further instructions regarding the field action.

The recalled product

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…
Manufacturer
Medtronic Navigation, Inc.
Category
Medical Device — Surgical Navigation Software
Hazard
Affected units
27

Distribution

Distributed nationwide across the United States.

The notice also names 15 states specifically:

Part of a larger recall action

This product is one of 7 recalled by Medtronic Navigation, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

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