System M ® Gas ModuleRecalls & reported problems
Spectrum Medical Limited · High Flow - (1.0 - 7.0 L/min) · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05060434420190), received between Feb 24, 2026 and Feb 24, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Computer Software 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.
Reports received per month
Most reported problems
Device problems
- Computer Software Problem1
- Incorrect Measurement1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 24, 2026Computer Software Problem; Incorrect Measurement
THE VCO2 IS ALWAYS AROUND 100, WHICH IS A COMPLETELY INACCURATE VALUE (NORMAL <70). THE PROBLEM DOESN'T SEEM TO ORIGINATE FROM THE EXHALED CO2 SENSOR, AS THE VALUE RETRIEVED FROM THE NEW ESSENZ CONSOLE IS CORRECT. THE PROBLEM THEREFORE APPEARS TO BE WITH THE MONITOR ITSELF (A VCO2 CALCULATION ISSUE?). THE SECOND PROBLEM CONCERNS THE PAO2 CALCULATION. THE READING DRIFTS SIGNIFICANTLY OVER TIME. (WE PERFORM ARTERIAL BLOOD GAS ANALYSIS EVERY 30 MINUTES TO RECALIBRATE THE SPECTRUM. THE ARTERIAL PAO2 READING IS ALWAYS VERY DIFFERENT FROM THE PAO2 DISPLAYED ON THE SPECTRUM.)
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24429177 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.