Medtronic Navigation Recalls StealthStation Software Applications
Medtronic Navigation is voluntarily recalling StealthStation software applications affected by Neurologica BodyTom/CereTom 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 classified as FDA Class II and is described as a voluntary field action. The source text does not report any injuries, illnesses, or deaths, and the hazard is related to software compatibility rather than a direct physical defect causing immediate harm.
Plain-English summary
Medtronic Navigation, Inc. has announced a voluntary field action for Medtronic Navigation StealthStation Software applications. The recall involves 27 units of the MACH Cranial Treon software, which is distributed in CD format with an instruction for use (IFU). The software is intended as an aid for precisely locating anatomical structures in open or percutaneous procedures.
The field action is being taken because the software applications are affected by Neurologica BodyTom/CereTom floor-based scanners. The affected products are Model Number 9730888, and all lot numbers manufactured by Medtronic Navigation are included in this recall.
The products were distributed worldwide, including nationwide in the United States and 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 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…
- Manufacturer
- Medtronic Navigation, Inc.
- Hazard
- Affected units
- 27
Distribution
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.
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