O2-Sensor MLF-16Recalls & reported problems
IT Dr. Gambert GmbH · Class 2
Quick summary
This IT Dr. Gambert O2-Sensor MLF-16 is an oxygen gas analyzer. Reports mostly describe oxygen sensors failing calibration upon receipt, with no patient involvement. There are 41 adverse event reports, with no deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 61
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 04250320600725), received between Apr 5, 2022 and Sep 16, 2026 — classified as 61 malfunctions.
The most frequently reported specific device problem is “Failure to Calibrate” (40 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.
Reports received per month
Most reported problems
Device problems
- Failure to Calibrate40
- Calibration Problem21
Patient problems
- No Clinical Signs, Symptoms or Conditions61
Recent adverse event reports
The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Calibration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794724 ↗MalfunctionSep 16, 2026Calibration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794478 ↗MalfunctionSep 16, 2026Calibration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794424 ↗MalfunctionSep 16, 2026Calibration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794406 ↗MalfunctionSep 16, 2026Calibration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794275 ↗MalfunctionSep 16, 2026Calibration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794198 ↗MalfunctionSep 16, 2026Calibration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50789031 ↗MalfunctionSep 16, 2026Calibration Problem
The manufacturer's subsidiary's service engineer reported that during preventative maintenance (PM) of the device, upon replacement of the oxygen (O2) sensor, the replacement O2 sensor failed calibration. The service engineer reinstalled the original O2 sensor. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50788979 ↗MalfunctionSep 16, 2026Calibration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50788948 ↗MalfunctionSep 16, 2026Calibration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50788400 ↗MalfunctionSep 16, 2026Calibration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787961 ↗MalfunctionSep 16, 2026Calibration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787947 ↗MalfunctionSep 16, 2026Calibration Problem
The manufacturer's subsidiary's service engineer reported that during preventative maintenance (PM) of the device, upon replacement of the oxygen (O2) sensor, the replacement O2 sensor failed calibration. The service engineer reinstalled the original O2 sensor. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787888 ↗MalfunctionSep 16, 2026Calibration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787878 ↗MalfunctionSep 16, 2026Calibration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787851 ↗MalfunctionSep 16, 2026Calibration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787796 ↗MalfunctionSep 16, 2026Calibration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787779 ↗MalfunctionSep 16, 2026Calibration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787708 ↗MalfunctionSep 16, 2026Calibration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787627 ↗MalfunctionSep 15, 2026Calibration Problem
The manufacturer's subsidiary's service engineer reported that during preventative maintenance (PM) of the device, upon replacement of the oxygen (O2) sensor, the replacement O2 sensor failed calibration. The service engineer reinstalled the original O2 sensor. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50773523 ↗MalfunctionFeb 23, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED THAT UPON RECEIPT OF THE DEVICE, THE OXYGEN (O2) SENSOR FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18766227 ↗MalfunctionJan 19, 2024Failure to Calibrate; Failure to Calibrate
UPON RECEIPT OF THE DEVICE, THE USER REPORTED THAT THE ELECTRONIC PATIENT GAS SYSTEM (EPGS) OXYGEN (O2) SENSOR FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18544019 ↗MalfunctionJan 19, 2024Failure to Calibrate; Failure to Calibrate
UPON RECEIPT OF THE DEVICE, THE USER REPORTED THAT THE ELECTRONIC PATIENT GAS SYSTEM (EPGS) OXYGEN (O2) SENSOR FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18543767 ↗MalfunctionJan 15, 2024Failure to Calibrate; Failure to Calibrate
UPON RECEIPT OF THE DEVICE, THE USER REPORTED THAT THE ELECTRONIC PATIENT GAS SYSTEM (EPGS) OXYGEN (O2) SENSOR FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18515139 ↗MalfunctionJan 15, 2024Failure to Calibrate; Failure to Calibrate
UPON RECEIPT OF THE DEVICE, THE USER REPORTED THAT THE ELECTRONIC PATIENT GAS SYSTEM (EPGS) OXYGEN (O2) SENSOR FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18515121 ↗
Other Analyzer, Gas, Oxygen, Gaseous-Phase devices
- NOxBOXi NOXBOX-INoxbox Ltd · Analyzer, Gas, Oxygen, Gaseous-Phase6 recalls5 deaths121 reports
- BIRD SENTRY2 30623-001Carefusion Corporation · Analyzer, Gas, Oxygen, Gaseous-Phase1 report
- MaxVenturi R211P03-036Maxtec, LLC · Analyzer, Gas, Oxygen, Gaseous-Phase1 report
- MAXO2 ME R230P01Maxtec, LLC · Analyzer, Gas, Oxygen, Gaseous-Phase1 report
- Vital Signs™ 8004463AirLife Finland Oy · ANALYZER, GAS, OXYGEN, GASEOUS-PHASE1 report
- Vital Signs™ 73319-HELAirLife Finland Oy · Analyzer, Gas, Oxygen, Gaseous-Phase1 report
- Oxygen Sensor MAX-125MMaxtec, LLC · Analyzer, Gas, Oxygen, Gaseous-Phase1 report
- MAXVENTURI R211P03-027Maxtec, LLC · Analyzer, Gas, Oxygen, Gaseous-Phase1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.