GCE RS-00500Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08592346004337), received between Mar 3, 2022 and Jul 15, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Fire” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K162433); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2026Fire

  User reported ''I'd been out and was about to charge the oxygen concentrator on my return home. A friend of the patient plugged the charger into the Zen-O andwhen she plugged it into the wall socket - or moved the plug in the socket - there was a loud bang and a burst of flameshot out from the oxygen concentrator. It was a huge shock for the ladies. According to the assistive technology centre technician who wentthere and replaced the concentrator with a new one, it looks as though a "[?]"gas explosion' had taken place inside the machine. There were black marks all round and onthe plug and connector."Event occured in Sweeden and was reported to the Swedish NCA - Swedish Medical Products Agency (Läkemedelsverket). no one was harmed , however custoemr considered there was potential to have caused harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25822511 ↗
• MalfunctionSep 10, 2025Fire; Fire

  REPORT FROM OXYGEN CONCENTRATOR DEVICE DISTRIBUTOR INDICATES INCIDENT OCCURING ON NURSING HOME , (B)(6) DESCRIBING 'BURNING BATTERY INSIDE THE DEVICE/ BURNING DEVICE' AND 'THE PATIENT WENT TO EAT AND THE MOBILE CONCENTRATOR SMOKED AND CAUGHT FIRE'. INSPECTION OF RETURNED DEVICE SHOWS EXTERNAL SIGNS OF FIRE TO IT'S CARRY CASE AND BURN HOLE THROUGH THE CANNULA HOUSING AND CARRY CASE AT THAT POINT, WHICH WOULD HAVE HAD POTENTIAL TO CAUSE HARM WHEN IT OCCURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23016051 ↗
• MalfunctionMay 9, 2025Overheating of Device; Overheating of Device

  DEVICE WAS RETURNED TO REPAIR CENTER WITH NO INFORMATION AND WAS MISSING BATTERIES AND BATTERY COVER. MELTED HOLE IN THE REAR OF THE DEVICE WAS OBSERVED. DISASSEMBLY AND FURTHER INSPECTION SHOWED ADDITIONAL MELTING OF THE BOTTOM OF IT'S BATTERY COMPARTMENT INDICATING THAT EXCESSIVE HEAT WAS GENERATED WITHIN THE REAR BATTERY PACK. EVIDENCE OF SMOKE/FUMES HAVING EXITED THE DEVICE WAS ALSO OBSERVED. ALTHOUGH NO REPORT OF HARM CAUSED TO USER/PATIENT , HIGH TEMPERATURE EVENT IS CONSIDERED TO HAVE POTENTIAL TO CAUSE HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21993760 ↗
• InjuryMar 3, 2022Therapeutic or Diagnostic Output Failure

  I BROUGHT A GCE ZENO PORTABLE OXYGEN CONCENTRATOR A YEAR AGO (2021) DUE TO NEEDING OXYGEN USAGE WHEN I'M MOBILE. I DID NOT GET MUCH USAGE OUT OF THE MACHINE THE FIRST YEAR BECAUSE OF THE MALFUNCTION AND I SENT THE MACHINE IN TO THE MEDICAL COMPANY THAT I PURCHASED THE OXYGEN MACHINE FROM IN LATE (B)(6) 2021 FOR REPAIRS. I GOT IT BACK (B)(6), 2021. I WAS ABLE TO USED IT FOR A WEEK AND WHEN I WAS OUT AT THE STORE THE MACHINE STOPPED WORKING AND DIED ON ME. LUCKILY I WAS ONLY 3 MINUTES FROM HOME AND WAS ABLE TO GET HOME SAFELY TO USE MY OXYGEN STATION AT HOME. THE MACHINE KEPT SHOWING "07: SERVICE!" EVERY TIME I TRIED TO TURN IT ON AND IT WOULD NOT WORK AND KEEPS BEEPING. I REPORTED THIS AND THE MANUFACTURER GCE SENT ME A NEW REPLACEMENT SINCE I NEVER GOT MUCH USE OUT OF THE FIRST MACHINE. I GOT THE REPLACEMENT (B)(6), 2022 AND RIGHT OUT OF THE BOX I CHARGED THE BATTERY AND THE ZENO OXYGEN CONCENTRATOR WORKED FINED BUT AFTER 2 MINUTES THE MACHINE BEEPED WITH AN ALARM WITH THE MESSAGE "CHECK VENT." I TURNED IT OFF AND TURNED IT BACK ON AND THE PROBLEM WENT AWAY. ON (B)(6) 2022, A FRIGHTENING AND LIFE THREATENING SITUATION HAPPENED TO ME USING THE NEW ZENO REPLACEMENT THAT I GOT. I WENT

  Patient problems: Dyspnea

  MAUDE report 13666343 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162433. One submission often covers many models, so check the product and lot details in each record.

• Z-1980-2025 · May 8, 2025 · Open, Classified
  GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S