neuromate planning station hardware neuroinspire PC - Desktop USRecalls & reported problems
Renishaw Mayfield · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03662724000444), received between Jun 23, 2026 and Jun 23, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Computer Software Problem” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Computer Software Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 23, 2026Computer Software Problem
DURING A DBS, NEUROINSPIRE INDICATED A COM FAULT. AFTER THIS, THE OPERATING ROOM PC SHUT DOWN, AND IT WAS UNABLE TO BE POWERED BACK ON. THE PC TOWER POWER LIGHT WOULD TURN ON, THE CD-ROM LIGHT WOULD FLASH, THE MONITOR WOULD DISPLAY A NO DP SIGNAL MESSAGE, AND THE PC WOULD THEN SHUT OFF. THE SURGEON HAD TO FINISH THE CASE VIA ARC & FRAME. THE OR PC WAS ATTEMPTED TO BE TURNED ON SEVERAL TIMES, INCLUDING MULTIPLE CHARGE RELEASES. FOLLOWING COMPLETION OF THE SURGERY, THE PC TURNED BACK ON. IN ANOTHER OCCASION THE SURGEON MAY HAVE HAD TO CANCEL THE PROCEDURE GIVING THE PATIENT ANAESTHETIC WITH NO THERAPEUTIC BENEFIT, THIS IS BEING REPORTED ON THIS BASIS OF THIS POTENTIAL INDIRECT HARM IF IT WERE TO OCCUR ON ANOTHER OCCASION.
Patient problems: Insufficient Information
MAUDE report 25595222 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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