Medtronic StealthStation Software Recalled Due to Scanner Compatibility Issues
Medtronic Navigation is voluntarily recalling 27 units of StealthStation software due to compatibility issues with specific floor-based scanners.
What this means for you
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 a voluntary field action for a software compatibility issue with specific scanners. No injuries, illnesses, or deaths are reported in the source text, and the hazard is theoretical or operational rather than a direct physical safety risk like a defect or contamination.
Plain-English summary
Medtronic Navigation, Inc. has announced a voluntary field action for the Medtronic Navigation StealthStation Software applications. This action affects software versions that are impacted by Neurologica BodyTom/CereTom floor-based scanners. 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 either open or percutaneous procedures. It is indicated for medical conditions where stereotactic surgery may be appropriate and where reference to a rigid anatomical structure, such as the skull, can be identified relative to imaging models or digitized landmarks. The recall involves 27 units in total, with Model Number 9730889. All lot numbers manufactured by Medtronic Navigation are affected.
The affected products were distributed worldwide, including nationwide in the United States across states such as 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. Users of the affected software should contact Medtronic Navigation for further instructions regarding the field action.
The recalled product
- Product
- MACH AxiEM 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 percutan
- 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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