LABSYSTEM™ PRO M00420020240Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729885948), received between Sep 1, 2023 and Sep 1, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Operating System Becomes Nonfunctional” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2023Operating System Becomes Nonfunctional; Operating System Becomes Nonfunctional

  IT WAS REPORTED THAT DURING A PROCEDURE, A LABSYSTEM PRO WAS SELECTED FOR USE. UNIT FROZE DURING THE CASE. ISSUE OCCURRED ABOUT IN THE MIDDLE OF A 3 HOUR CASE. ACCOUNT WAS PACING FROM THE BEGINNING. TROUBLESHOOTING WITH THE ACCOUNT EXTENDED TIMING FOR PACING FROM 45 MINUTES TO 60 MINUTES. PROCEDURE WAS NOT ABLE TO BE COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS OCCURRED. UNIT WILL NOT BE RETURNED SINCE IT WAS REPAIRED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17670484 ↗