LABSYSTEM™ PRO M0042002034R0Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729935902), received between Oct 19, 2021 and Dec 19, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2022Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT DURING A PROCEDURE USING A LABSYSTEM PRO CPU THE COMPUTER WOULD NOT TURN ON. THEY STATED THAT DURING PREVIOUS PROCEDURES IT WOULD TAKE MANY ATTEMPTS FOR THE CPU TO TURN ON. DURING THIS PROCEDURE THEY COULD NOT GET THE CPU TO TURN ON AT ALL AND THE PROCEDURE HAD TO BE CANCELLED AFTER THE PATIENT WAS SEDATED. THERE WERE NO PATIENT COMPLICATIONS. IT IS NOT CURRENTLY KNOWN IF THE COMPUTER WILL BE RETURNED AS IT HAS NOT BEEN DECIDED IF AN ATTEMPT WILL BE MADE TO REPAIR THE CPU OR REPLACE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16008599 ↗
• MalfunctionOct 19, 2021Unexpected Shutdown; Unexpected Shutdown

  DURING A PROCEDURE INVOLVING A LSPRO II EP RECORDING SYSTEM, ALL THE LSPRO ELEMENTS SHUT DOWN. THE ISSUE WAS UNABLE TO BE RESOLVED AND THE PROCEDURE WAS CANCELLED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12657184 ↗