Medtronic Navigation Recalls Synergy Cranial S7 Software Applications
Medtronic Navigation is conducting a voluntary field action for Synergy Cranial S7 software applications 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 source text describes a voluntary field action without reporting any injuries, illnesses, or deaths. Per the rubric, voluntary precautionary recalls 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, specifically the Synergy Cranial S7. 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 open or percutaneous procedures.
The field action is being conducted because the affected software applications are associated with Neurologica BodyTom/CereTom floor-based scanners. The source text does not specify the exact nature of the defect or the specific risk to patients, but indicates a need for a field action regarding these specific scanner types.
A total of 27 units are affected by this action. The distribution was worldwide, including nationwide distribution in the United States across states such as New York, Arizona, Arkansas, North Carolina, California, Ohio, Michigan, Indiana, Massachusetts, Texas, Oregon, Colorado, Missouri, and Utah. International distribution included India, Australia, and the Russian Federation. All lot numbers manufactured by Medtronic Navigation for Model Number 9733763 are affected.
The recalled product
- Product
- Synergy Cranial S7. 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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