Medtronic Navigation StealthStation Software Voluntary Field Action
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 text describes a voluntary field action without reporting any specific injuries, illnesses, or deaths. Per the rubric, voluntary precautionary actions without reported harm are classified as Moderate.
Plain-English summary
Medtronic Navigation, Inc. has announced a voluntary field action for the Medtronic Navigation StealthStation Software applications. This action specifically addresses software affected by Neurologica BodyTom/CereTom floor-based scanners.
The affected product is the Synergy Spine software application, which is distributed in CD format with an Instruction for Use (IFU). The software is part of the StealthStation System, intended as an aid for precisely locating anatomical structures in open or percutaneous procedures. The system is indicated for medical conditions where stereotactic surgery may be appropriate and where reference to a rigid anatomical structure can be identified relative to imaging models or digitized landmarks.
A total of 27 units are affected by this field action. The distribution pattern includes worldwide distribution, with US nationwide presence in states including 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. The affected model number is 9733686-02, and all lot numbers manufactured by Medtronic Navigation are affected.
The recalled product
- Product
- Synergy Spine. 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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