Quantum QLS1-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05060434421906), received between Mar 2, 2026 and Mar 3, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Calibration 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. 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.

• MalfunctionMar 3, 2026Calibration Problem

  HEAD OF PERFUSION (B)(6) REPORTED ERROR 10810 FOR THE QUANTUM LEVEL SENSOR DURING INITIATION MODE. THE SENSOR HAS BEEN DEACTIVATED AND THE CASE FINISHED SUCCESSFULLY. UPON REQUEST THERE WERE NO CONSEQUENCES OR HARM FOR THE PATIENT AS CONFIRMED BY THE PERFUSIONIST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24493970 ↗
• MalfunctionMar 2, 2026Device Sensing Problem

  USER REPORTED THAT THE LEVEL SENSOR WAS INACCURATELY ALARMING DURING THE PROCEDURE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24480668 ↗