GCE RS-00600Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08592346658110), received between May 9, 2025 and Jul 25, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2025Overheating of Device; Overheating of Device

  DEVICE RETURNED FOR SERVICE WITH NO REFERENCE TO BEING A DEVICE OF SPECIAL INTEREST OR ANY SIGNIFICANT/ADVERSE EVENT OCCURRING WITH IT, BY CUSTOMER - (B)(6). DURING SERVICING THE DEVICE'S INTERNAL INSPECTION FOUND BATTERY BOARD OVERHEATING AND BURNED SURFACES WITH EVIDENCE OF SOME SMOKE GENERATION. BELIEVE INCIDENT OCCURRED WHILST DEVICE WAS IN (B)(6). POTENTIAL TO HAVE CAUSE HARM DETERMINED BY REPAIR FACILITY IN CZECH REPUBLIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22606964 ↗
• MalfunctionMay 9, 2025Overheating of Device; Overheating of Device

  FRENCH CUSTOMER (NOT END USER/PATIENT) DESCRIBED 'BATTERY FIRE' WITH PHOTOGRAPHS WHICH WERE NOT DETAILED ENOUGH TO DETERMINE SEVERITY. DEVICE (B)(6) AND BATTERY WAS RETURNED TO CZECH REPAIR SITE WHERE FIRST INSPECTION SUGGESTED CATEGORISE HIGH SEVERITY FOR FURTHER INVESTIGATION. DEVICE AND BATTERY WERE SENT TO LEGAL MANUFACTURER UN UK FOR FURHTHER INVESTIGATION. DEVICE NEARLY 2 YEARS OLD WITH ONLY 35HRS RUNTIME. NO SIGNS OF ANY INAPPROPRIATE HANDLING DAMAGE OR CONTAMINATION. ERROR LOG HAS 32X6 (LOW BATTERY) AND 23X4 (CHECKVENTS/LOW PURITY) MESSAGES RECORDED. EXCESSIVE DISCHARGE OF BATTERY ENERGY AT THE +, C AND D TERMINALS OF BATTERY CONNECTOR, WHICH APPEARS CENTERED ON THE BATTERY BOARD, UNDER 5 PIN BATTERY CONNECTOR. HEAT CAUSED EVEN THE LEGS OF THE THREE CONNECTOR CONTACTS TO BE MELTED. XRAY FOUND NO SHORTING ELEMENT IN BATTERY CONNECTOR. BOARD IS BURNED AWAY AND HEAT AND FUMES HAVE CAUSED DAMAGE TO SURROUNDING PLASTICS (MELTED AND OR DISCOLOURED). BATTERY INDICATES NO RESIDUAL CHARGE. BATTERY BOARD TRACKABILITY RECORD IN IMPROBITY WAS FOUND TO BE WRONG (COPY OF MOTHERBOARD S/N!) BUT, BASED ON DEVICES MANUFACTURED AT SAME TIME, BATTERY BOARD BATCH DETERMINED TO BE (B)(6). FINDIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21993674 ↗

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