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.
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 specific hazards, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Medtronic Navigation, Inc. has announced a voluntary field action for the Fusion ENT Application. This software application is distributed in CD format with an instruction for use (IFU) and is part of the StealthStation System, which is intended to aid in precisely locating anatomical structures during open or percutaneous procedures.
The recall involves 27 units of the Fusion ENT Application, identified by Model Number 9733467. The source text indicates that all lot numbers manufactured by Medtronic Navigation are affected. The field action is associated with Neurologica BodyTom/CereTom floor-based scanners.
The affected products were distributed worldwide, including in the United States (specifically in NY, AZ, AR, NC, CA, OH, MI, IN, MA, TX, OR, CO, MO, UT, and IL) and in the countries of India, Australia, and the Russian Federation. The source text does not specify the exact nature of the defect or the specific steps consumers or healthcare providers should take beyond the announcement of the voluntary field action.
The recalled product
- 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…
- 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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