405LSR-SIRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05700574033880), received between Dec 20, 2023 and Dec 21, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Smoking” (2 reports).

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 21, 2023Melted; Smoking; Environmental Particulates; Melted; Smoking; Environmental Particulates

  CUSTOMER REPORTED "THE INSTRUMENT STARTED SMOKING DURING USE." PICTURES WERE PROVIDED CONFIRMING THAT A PART INSIDE THE INSTRUMENT HAD BURNED AND MELTED. THE LAB TECHNICIAN IMMEDIATELY TURNED THE POWER OFF AND THE INSTRUMENT STOPPED SMOKING. FIELD SERVICE ENGINEER (FSE) WAS ON SITE TO EVALUATE THE DAMAGE NOTING THAT THE DEBRIS/ SMOKE PARTICLES ARE ALL OVER THE INSTRUMENT. THE TOP COVER IS ALSO PARTIALLY BURNT. ADDITIONALLY, FSE ASSESSED THE LAB ENVIRONMENT AND RECOMMENDED IN HOUSE REPAIR DUE TO THE EXTENT OF THE DAMAGE. THE INSTRUMENT WILL BE SHIPPED BACK TO THE MANUFACTURING SITE FOR FURTHER INVESTIGATION. DIAGNOSTICS WERE NOT ALTERED. THERE WAS NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM REPORTED. THE INVESTIGATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE PROVIDED WHEN NEW PERTINENT INFORMATION IS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18375474 ↗
• MalfunctionDec 20, 2023Fire; Smoking; Fire; Smoking

  CUSTOMER REPORTED "THE INSTRUMENT SUDDENLY STARTED SMOKING." CUSTOMER TOOK THE TOP OFF AND SAW A PART INSIDE THE INSTRUMENT CAUGHT FIRE AND WAS PRODUCING FLAME. THE INSTRUMENT STOPPED SMOKING ONCE TURNED OFF. THE CUSTOMER WAS ABLE TO COMPLETE PATIENT TESTING. DIAGNOSTICS WERE NOT ALTERED. THERE WAS NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM REPORTED. THE INSTRUMENT WAS RETURNED FOR IN-HOUSE REPAIR. VACUUM RELAY ON MAIN PRINTED CIRCUIT BOARD (PCB) WAS FOUND TO BE BURNT. THE UNIT WAS CLEANED, AND MAIN PCB WAS REPLACED. 1170204 1.47 SOFTWARE DOWNLOADED. THE INSTRUMENT HAS BEEN CALIBRATED AND TESTED AND IS FULLY OPERATIONAL AND AVAILABLE FOR USE. THE INSTRUMENT IS READY TO BE SHIPPED BACK TO CUSTOMER SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18367375 ↗