OxyGo Fit 630Recalls & reported problems
Inogen, Inc. · OxyGo Fit (Inogen One G4 Oxygen Concentrator) (10-07068-XX-XX) (1400-2000) · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00817131020124), received between Apr 15, 2026 and Apr 15, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fire” (1 report).
1 other recall cover devices cleared under the same FDA submission (K032818); they may or may not involve this specific model.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fire1
- Smoking1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 15, 2026Fire; Smoking
IT WAS REPORTED THAT THE PATIENT'S UNIT HAD CAUGHT ON FIRE DURING A CAR RIDE. THE PATIENT DID NOT HAVE ANY INJURIES, HOWEVER THEY DID NOT HAVE OXYGEN FROM THE UNIT FOR THE REST OF THEIR CAR RIDE. THE INOGEN TEAM ATTEMPTED TO CONTACT THE PATIENT FOR FURTHER INFORMATION THREE TIMES WITH NO RESPONSE.
Patient problems: Insufficient Information
MAUDE report 24886608 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K032818. One submission often covers many models, so check the product and lot details in each record.
- Z-1368-05 · Aug 1, 2005 · TerminatedPortable Oxygen Generator
Other Generator, Oxygen, Portable devices
- DeVilbiss 525DSDevilbiss Healthcare LLC · Generator, Oxygen, Portable2 recalls14 deaths287 reports
- Inogen One G5 Oxygen Concentrator - Bluetooth 1260 BluetoothInogen, Inc. · Generator, Oxygen, Portable3 deaths235 reports
- EverFlo EverFlo w/O2 Percentage Indicator, 230V, EURespironics, Inc. · Generator, oxygen, portable5 deaths112 reports
- Inogen One G3 Oxygen Concentrator 1050Inogen, Inc. · Generator, Oxygen, Portable2 deaths111 reports
- DeVilbiss 125DDevilbiss Healthcare LLC · Generator, Oxygen, Portable2 recalls1 death3 reports
- EverFlo EVERFLO NON-O2 Percentage Indicator, 120V, US,CARespironics, Inc. · Generator, oxygen, portable19 deaths80 reports
- EverFlo EVERFLO w/Oxygen Percentage Indicator, 120V US, CARespironics, Inc. · Generator, oxygen, portable2 deaths71 reports
- SimplyGo Mini SimplyGo Mini, USRespironics, Inc. · Generator, oxygen, portable1 recall1 death5 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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