LABSYSTEM™ PRO M00420020230Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729884941), received between Sep 25, 2024 and Jul 29, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Connection 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2026Signal Artifact/Noise

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50077371 ↗
• MalfunctionJul 10, 2026Device Displays Incorrect Message; Reset Problem

  IT WAS REPORTED THAT THE AMPLIFIER BROKE DOWN MID-CASE. DURING A PROCEDURE, A LABSYSTEM PRO CLEARSIGN II AMPLIFIER WAS SELECTED FOR USE. UPON SYSTEM STARTUP, THE ERROR MESSAGE "BEFORE CONTINUING YOU MUST RESET THE AMPLIFIER" WAS DISPLAYED. TROUBLESHOOTING WAS PERFORMED, INCLUDING TWO HARD RESETS AND POWERING ON THE SYSTEM USING THREE TO FOUR DIFFERENT STARTUP SEQUENCES; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. AFTER THE FUSE BOX WAS REMOVED, THE LABSYSTEM PRO WAS SUCCESSFULLY RESTARTED. DESPITE THE SUCCESSFUL RESTART, THE PROCEDURE WAS SUBSEQUENTLY CANCELLED WHILE THE PATIENT REMAINED UNDER GENERAL ANESTHESIA. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25781212 ↗
• MalfunctionSep 25, 2024Failure to Power Up; Connection Problem; Failure to Power Up; Connection Problem

  THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION. DURING AN EVENT, THE LABSYSTEM PRO EP RECORDING SYSTEM - CLEARSIGN II AMPLIFIER WAS SELECTED FOR USE. IT WAS REPORTED THAT AMPLIFIER WAS NOT FUNCTIONING. THE AMPLIFIER WAS STOPPED RESPONDING MID-PROCEDURE. IT WAS NOTED THAT HEPARINE SALINE FLUID SPLASHED ONTO ELECTRICAL EQUIPMENT PENDANT AND POTENTIALLY ENTERED A POWER SOCKET AND CIRCUIT BREAKER, THUS, LOSING POWER TO ALL EQUIPMENT. THE EQUIPMENT WAS REBOOTED WITHOUT ISSUES EXCEPT FOR THE CLEARSIGN AMPLIFIER. CONNECTION BETWEEN WORKSTATION COULD NOT BE RESTORED DESPITE ALL TROUBLESHOOTING SUGGESTED BY TECHNICAL SUPPORT. DUE TO THIS THE PROCEDURE WAS CANCELLED. PATIENT HAD BEEN SEDATED AT THE TIME OF CANCELLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20306967 ↗