Medtronic Navigation Recalls StealthStation Software Applications
Medtronic Navigation is conducting a voluntary field action for 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 source describes a voluntary field action for a medical device software application without reporting specific injuries, illnesses, or FDA Class I classification, fitting the criteria for a moderate severity voluntary precautionary action.
Plain-English summary
Medtronic Navigation, Inc. has announced a voluntary field action for Medtronic Navigation StealthStation Software applications. The software is distributed in CD format with an Instruction for Use (IFU) and 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 source text does not specify the exact nature of the defect or the specific risk associated with the affected scanners.
The recall involves 27 units in total. Distribution was worldwide, including nationwide distribution in the United States across states such as NY, AZ, AR, NC, CA, OH, MI, IN, MA, TX, OR, CO, MO, and UT, as well as in India, Australia, and the Russian Federation. All lot numbers manufactured by Medtronic Navigation are affected. Users should contact Medtronic Navigation for further instructions regarding this field action.
The recalled product
- 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…
- 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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