LABSYSTEM™ PRO M00420020210Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729884842), received between Jul 18, 2022 and Sep 25, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Data 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2025Defective Device; Data Problem; Defective Device; Data Problem

  THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION. IT WAS REPORTED THAT DURING THE PROCEDURE, AN LABSYSTEM PRO CLEARSIGN II AMPLIFIER WAS SELECTED FOR USE. IT WAS FOUND THAT THE SAP OF THE DEVICE WAS FLASHING YELLOW AND DATA COULD NOT BE EXPORTED. THERE WAS NO ERROR MESSAGE DISPLAYED. EQUIPMENT NEEDS REPLACEMENT. THIS ISSUE LED TO THE PROCEDURE BEING CANCELLED/RESCHEDULED. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23151066 ↗
• MalfunctionAug 31, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A LABSYSTEM PRO CLEARSIGN II AMPLIFIER PRESENTED AN ISSUE. THE DEVICE BP1 AND BP2 MODULES ARE NOT WORKING. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO FURTHER INFORMATION WAS PROVIDED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS AS IT WILL BE CHECKED ON SITE. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17666637 ↗
• MalfunctionNov 29, 2022Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT PRIOR TO A PROCEDURE THE CLEARSIGN II AMPLIFIER FAILED TO TURN ON. THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15879792 ↗
• MalfunctionJul 18, 2022Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING A PROCEDURE USING A LABSYSTEM PRO AMPLIFIER THEY RECEIVED FREQUENT ERROR MESSAGES AND WERE UNABLE TO COMPLETE THE PROCEDURE DUE TO THE REPEATING ERROR. THERE WERE NO PATIENT COMPLICATIONS. THE AMPLIFIER IS NOT GOING TO BE RETURNED AS IT WAS REPAIRED ON SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15042968 ↗