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.
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 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 procedu
- 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.
See all 7 products in this recall →Related recalls
Same manufacturer · Medtronic Navigation, Inc.
See all →- HighMedtronic Percutaneous Reference Pins May Not Fit Properly
FDA (Devices) · 2025-02-05
- HighStealthStation S8 Spine Surgery Navigation System Recalled for Software Defects
FDA (Devices) · 2024-10-16
- SevereStealth S8 neurosurgical navigation software display error affecting surgical guidance
FDA (Devices) · 2024-05-15
- HighMedtronic Percutaneous Surgical Pins Recalled Due to Potential Fitting Defects
FDA (Devices) · 2024-01-17
- HighMedtronic Percutaneous Pins Recalled for Potential Fitting and Removal Issues
FDA (Devices) · 2024-01-17
Same hazard · software defect
See all →- HighMidmark IQecg Digital ECG Software Recall for Inaccurate Waveforms
FDA (Devices) · 2026-09-02
- HighMidmark Digital ECG Software Recall for Incorrect Waveform Display
FDA (Devices) · 2026-09-02
- ModerateEndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- HighMitsubishi Recalls Outlander Models for Rearview Camera Software Defect
NHTSA · 2026-08-25