LABSYSTEM™ PRO M0042001267H0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729883296), received between Jan 15, 2021 and Jan 15, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (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.

• MalfunctionJan 15, 2021Device Displays Incorrect Message

  IT WAS REPORTED THAT A CLEARSIGN AMPLIFIER WAS SELECTED TO BE USED IN A PROCEDURE. HOWEVER IT WAS NOTED DURING PREPARATION THE ERROR 'BEFORE CONTINUING YOU MUST RESET THE AMPLIFIER'. THE INSTRUCTIONS FOR REBOOTING THE FOLLOWED 5 TIMES WITH THE SAME MESSAGE OCCURRING. REPLACING THE CAT5 CABLE DID NOT RESOLVE THE ISSUE. THE PROCEDURE WAS CANCELED DUE TO THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED USING THE NON-BOSTON SCIENTIFIC SYSTEM AND NOT CANCELED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11178836 ↗