Quantum QFS4-ST-120Recalls & reported problems
Spectrum Medical Limited · Quantum Flow Sensor - ID 3/8" x Wall 3/32" (OD 9/16") 1.2m · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05060434423269), received between Apr 16, 2025 and Jun 5, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Imprecision” (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
- Imprecision1
- Incorrect Interpretation of Signal1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 5, 2025Imprecision; Imprecision
USER REPORTED THAT THE FLOW SENSOR WAS MISREADING FLOW RATE COMPARED TO OTHER SENSORS. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22150571 ↗MalfunctionApr 16, 2025Incorrect Interpretation of Signal; Incorrect Interpretation of Signal
USER REPORTED INACCURATE BUBBLE ALARMS, WHICH CAUSED THE OCCLUDER TO CLAMP AND FLOW TO STOP. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21847391 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.