Model note · Surgical Robot
Mazor X Stealth Edition robotic guidance system
Mazor X Stealth Edition is Medtronic's spine surgery robot. It joins robotic trajectory guidance with Stealth optical navigation so the surgeon can place pedicle screws and instruments along a plan made on the patient's CT. A surgical arm mounted on the operating table holds a tool guide on the planned path, while a navigation camera tracks instruments. It is widely installed in spine centres, and its recalls are mostly software related.
The model
Maker, model and type.
- Maker
- Mazor Robotics Ltd. (Medtronic)
- Model
- Mazor X Stealth Edition robotic guidance system (REF TPL0059)
- Device type
- Surgical Robot
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| FDA classification | Stereotaxic instrument, 21 CFR 882.4560, Class II, product codes OLO (primary) and LLZ | Source |
| Latest clearance | K251316, Mazor X System / Mazor X Stealth Edition, decided 11 September 2025 (predicate K230064) | Source |
| System components | Workstation with software, surgical system with arm and tool guide, navigation camera, accessories, instruments and disposable kits | Source |
| Navigation camera | NDI Vega Polaris optical camera, 75 kg, 1.9 x 0.65 x 0.61 m | Source |
| Workstation | 1.85 x 1.20 x 0.64 m, 185 kg | Source |
| Surgical system (arm unit) | 0.92 x 0.63 x 0.58 m, 25 kg | Source |
| Stated accuracy | System mean accuracy under 1.5 mm; navigation mean positional error under 2 mm and mean trajectory error of 2 degrees | Source |
| Power | 110 to 120 VAC 60 Hz, 220 to 240 VAC 50 Hz, or 100 VAC 50/60 Hz; maximum 1000 VA; IEC 60601-1 compliant | Source |
| Imaging interfaces | O-arm imaging system, 2D C-arm and 3D C-arm; converts 2D fluoroscopic projections into a 3D volume | Source |
| Integrated navigated drills | Medtronic Stealth-Midas and Stealth-Midas MR8 navigated drill systems | Source |
Recalls
Known FDA recalls.
- Z-1122-20262025-12-10
Software errors that can cause incorrect surgical instrument positioning during spinal surgery.
FDA record - Z-3156-20242024-07-17
Lagging navigation display or mismatch between navigated screw and displayed screw information.
FDA record - Z-0101-20242023-09-05
Software correction for versions 4.2.2 and 5.0.1.
FDA record - Z-2330-20202019-12-05
Positioner Type II could let the surgical system detach from the operating table.
FDA record
Safety
Safety warnings from the record.
- Software errors in some versions can cause incorrect instrument positioning during spinal surgery; Medtronic issued mitigations to follow until the update is installed. Source
- A surgical system that detaches from the table could fall onto the patient and cause blunt injury. Source
- A mismatch between the navigated screw and the on screen screw information was reported in one software release. Source
Sources
Where this note comes from.
- Medtronic Mazor X Stealth Edition product page (Singapore)
- FDA 510(k) K251316 summary, Mazor X System / Mazor X Stealth Edition
- openFDA recall search, Mazor
- openFDA MAUDE problem counts, brand Mazor X
Not covered: No public Mazor X service manual or error code list was found, so errorCodes is empty. The Medtronic product page renders without readable content, so all specifications come from the FDA 510(k) summary. The Appendix A mitigations in the December 2025 recall notice were not reproduced in the FDA record. MAUDE counts are reports, not failure rates.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Surgical Robot