SafeOp 3 AIX11240Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00190376517506), received between Jul 10, 2025 and May 27, 2026 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Unable to Obtain Readings” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 13, 2026Open, Classified

   Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication between the Patient Interface and Tablet, and prompts requiring system reboot; may result in increased operative time and surgical plan change.

   Z-2793-2026 · Root cause: Software Design Change · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Unable to Obtain Readings

  DURING A SPINAL PROCEDURE USING INTRAOPERATIVE NEUROMONITORING, THE SYSTEM WOULD NOT DISPLAY FREE RUN EMG WAVEFORMS. THE CASE PROCEEDED WITHOUT THE USE OF FREE RUN EMG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25306989 ↗
• MalfunctionMar 6, 2026Unable to Obtain Readings

  DURING A SPINAL PROCEDURE USING INTRAOPERATIVE NEUROMONITORING, THE LEFT HAND FREE-RUN EMG REPORTEDLY WOULD ONLY DISPLAY IN ONE VIEW AFTER ABOUT 30-40 MINUTES OF NORMAL ACTIVITY. THE MEPS RAN PROPERLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531926 ↗
• InjuryJan 27, 2026Malposition of Device

  A PATIENT UNDERWENT A SPINAL PROCEDURE ON (B)(6) 2025 IN WHICH INTRAOPERATIVE NEUROMONITORING WAS UTILIZED. DURING THE PROCEDURE TO4 TESTING WAS PASSING WITH 4/4, AND TEMG SCREW TESTING RESULTS SHOWED > 20MA. POSTOPERATIVE CT SCANS REVEALED A MEDIAL PEDICLE WALL BREACH OF THE S1 SCREW. THE PATIENT HAD REVISION SURGERY ON (B)(6) 2025 IN WHICH THE SCREW WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24193393 ↗
• MalfunctionDec 15, 2025Unable to Obtain Readings; Unable to Obtain Readings

  DURING A SPINAL PROCEDURE, THE UNIT WAS NOT DISPLAYING SEMG ACTIVITY. THE TABLET WAS RESTARTED, WHICH RESOLVED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23803902 ↗
• MalfunctionDec 5, 2025Unable to Obtain Readings; Unable to Obtain Readings

  DURING A SPINAL PROCEDURE USING INTRAOPERATIVE NEUROMONITORING, FREE-RUN EMG REPORTEDLY FAILED TO DISPLAY. THE MEPS WERE STUCK IN A STIMULATING STATE AND WOULD NOT REGISTER. IN ADDITION, THE ELECTRODE TEST WOULD NOT REGISTER AFTER A REBOOT. THE PATIENT INTERFACE AND TABLE WERE RESTARTED TWICE TO RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23733330 ↗
• MalfunctionDec 5, 2025Unable to Obtain Readings; Unable to Obtain Readings

  DURING A SPINAL PROCEDURE, THE NEUROMONITORING SYSTEM WOULD NOT DISPLAY ANY FREE-RUN EMG ACTIVITY. THE SYSTEM WAS SWITCHED OUT TO CONTINUE THE CASE SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23733255 ↗
• InjuryJul 16, 2025Incorrect, Inadequate or Imprecise Result or Readings; Malposition of Device; Incorrect, Inadequate or Imprecise Result or Readings; Malposition of Device

  A PATIENT UNDERWENT A SPINAL PROCEDURE AT THE L4-L5 LEVEL, DURING WHICH INTRAOPERATIVE NEUROMONITORING WAS UTILIZED. POSTOPERATIVELY, THE PATIENT DEVELOPED NEW-ONSET LEFT LEG PAIN. RADIOGRAPHIC IMAGING REVEALED A MEDIAL BREACH OF THE LEFT L5 PEDICLE SCREW. FOUR MONTHS AFTER THE INITIAL SURGERY, REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE THE HARDWARE.

  Patient problems: Limb Pain

  MAUDE report 22522090 ↗
• InjuryJul 10, 2025Unable to Obtain Readings; Unable to Obtain Readings

  AT THE START OF A SPINAL PROCEDURE, THE NEUROMONITORING SYSTEM FAILED TO DISPLAY ANY FREE-RUN EMG ACTIVITY. MULTIPLE ATTEMPTS TO RESTART BOTH THE PATIENT INTERFACE AND THE TABLET WERE UNSUCCESSFUL, RESULTING IN THE PROCEDURE BEING ABORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22471935 ↗