Skip to content

neuro|mate® frameless Gen II stereotactic system neuro|mate v1.5Recalls & reported problems

Renishaw Mayfield · neuro|mate® is an image-guided, computer-controlled, 5-axis articulated arm. It is intended for use in an operating room to position and orientate as prescribed by the surgeon a guide into which the surgeon can manually insert standard stereotactic instruments. neuro|mate® provides the surgeon with precise, reliable, and reproducible mechanical assistance in order to guide instruments during surgical interventions. neuro|mate® could be considered as a motorised stereotactic frame controlled by interactive PC-based imaging software which provides three-dimensional images of the anatomical structures of the brain as well as the target points. The neuro|mate® is a configurable medical device that is composed of a mobile support with or without a spacer, an arm, a planning trolley (with a planning station and a planning software), a remote control and cables. · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03662724000024), received between May 22, 2017 and Sep 26, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Unexpected Therapeutic Results” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Unexpected Therapeutic Results2

Patient problems

  • No Known Impact Or Consequence To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 26, 2017Unexpected Therapeutic Results; Unexpected Therapeutic Results

    DURING A SURGERY AT (B)(6) HOSPITAL, SOME TRAJECTORIES WERE ESTIMATED OUTSIDE THE ACCURACY SPECIFICATION OF THE PRODUCT. THE ESTIMATION OF THE ERROR BY THE SURGEON IS 4-5 MM. WHILE, THE ERROR SHOULD BE WITHIN 3MM. INITIAL FEEDBACK FROM THE TREATING SURGEON CONFIRMED THAT THE PATIENT IS DOING FINE AND THERE IS NO EVIDENCE OF HAEMORRHAGE ON THE POST OPERATION CT SCAN.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6893008 ↗
  • MalfunctionMay 22, 2017Unexpected Therapeutic Results; Unexpected Therapeutic Results

    DURING A SURGERY AT (B)(6) HOSPITAL IN (B)(6), A TRAJECTORY EXECUTED BY THE ROBOT DID NOT CORRESPOND TO THE PLANNED ONE. IT HAD A POSITION TOO ANTERIOR REGARDING THE SURGEON'S PLANNING. THE ISSUE WAS DETECTED BY THE SURGEON BEFORE INTRODUCING THE ELECTRODE BECAUSE THE TRAJECTORY WAS CLEARLY NOT ON ITS PLANNED POSITION. A FIELD SERVICE ENGINEER WAS ON SITE DURING THE SURGERY. THEY RECREATED A TRAJECTORY BY USING ITS COORDINATES AND THE ROBOT REACHED THE CORRECT POSITION WITHOUT ANY PROBLEM. THEY FAILED TO REPRODUCE THE ISSUE ON SITE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6580933 ↗

Other Neurological Stereotaxic Instrument devices

All Neurological Stereotaxic Instrument devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page