Luna® G3 APAP LG3600 (UDI 06948538363331)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 06948538363331), received between May 26, 2024 and Jan 29, 2026 — classified as 2 deaths, 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Device Emits Odor” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 18, 2026.

Recalls naming this device

1. Jul 15, 2026Class IOpen, Classified

   Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse

   Z-2979-2026 · Root cause: No Marketing Application · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• DeathJan 29, 2026Adverse Event Without Identified Device or Use Problem

  INFORMATION FROM THE INITIAL MEDWATCH REPORT ¿ 3B MEDICAL, INC. DBA REACT HEALTH WAS CONTACTED BY A DURABLE MEDICAL EQUIPMENT (DME) PROVIDER ADVISING THAT A PATIENT HAD PASSED AWAY WHILE USING A LUNA G3 APAP DEVICE. THE DME HAD BEEN CONTACTED BY THE PATIENT'S REHABILITATION FACILITY REQUESTING ASSISTANCE WITH OBTAINING THE DEVICE¿S ELECTRONIC DATA FOR REVIEW AS PART OF THEIR INVESTIGATION. ACCORDING TO THE DME, THE PATIENT HAD BEEN USING THIS DEVICE FOR ABOUT A YEAR, ALONG WITH A RESMED AIRFIT F20 FULL FACE MASK (LARGE). THE PATIENT WAS NOT USING THE CPAP AS A LIFE-SUPPORTING DEVICE. ON THE DAY THAT THE PATIENT PASSED AWAY, THE FACILITY ADVISED THAT THERE WERE NO ABNORMALITIES AS FAR AS TREATMENTS, MEDICATION ADMINISTRATION, NOR WERE THERE ANY ABNORMAL MANIFESTATIONS OF HIS PHYSICAL SYMPTOMS. THE REHABILITATION FACILITY CONFIRMED THAT THE MASK WAS ON THE PATIENT ON THE NIGHT OF (B)(6) 2025 AND INTO THE MORNING OF (B)(6) 2025, HOWEVER THE FACILITY COULD NOT CONFIRM WHETHER OR NOT THE DEVICE WAS POWERED ON. THE PATIENT WAS NOT TRANSPORTED TO THE HOSPITAL FOR TREATMENT. EMS WAS CONTACTED AND THEY PRONOUNCED HIS DEATH AT THE FACILITY. THE DME DOWNLOADED THE DEVICE¿S SD CARD AND PROVIDE

  Patient problems: Insufficient Information

  MAUDE report 24212268 ↗
• DeathJan 28, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THE MANUFACTURER RECEIVED A COMPLAINT FROM THE IMPORTER. THE CONTENT OF THE COMPLAINT WAS AS FOLLOWS: CUSTOMER REPORTED: MY TEAM RECEIVED A CALL FROM (B)(4) ASKING FOR A DOWNLOAD ON A CPAP MACHINE. THEY NOTIFIED US THAT THEY WERE CONTACTED BY (B)(4) ON A MUTUAL PATIENT AND WERE NOTIFIED THAT THE PATIENT PASSED WHILE USING THE DEVICE. AFTER SPEAKING WITH (B)(4) - THEY ARE WANTING TO DOUBLECHECK THAT A MANUAL DOWNLOAD MATCHES WHAT WAS PULLED ON REACT CONNECT. THEY WILL BE BRINGING THE DEVICE TO US TO PULL A DL ON THE SD CARD. PER THE REACT CONNECT DL, THE PATIENT DID NOT USE THE DEVICE THE NIGHT OF HIS PASSING ON (B)(6) 2025. WE WILL QUARANTINE THE DEVICE AFTER PULLING THE SD CARD. THIS DEVICE IS (B)(4) OWNED BUT WAS PROVIDED BY FOCUS. THERE IS NO ALLEGATION OF THE DEVICE CAUSING OR CONTRIBUTING TO THE DEATH. ON (B)(6) 2026, MANUFACTURER BMC RECEIVED THE 3500A REPORT THAT IMPORTER REACT HEALTH WAS ABOUT TO SUBMIT. THE CONTENT OF THE REPORT IS AS FOLLOWS:3B MEDICAL, INC. DBA REACT HEALTH WAS CONTACTED BY A DURABLE MEDICAL EQUIPMENT (DME) PROVIDER ADVISING THAT A PATIENT HAD PASSED AWAY WHILE USING A LUNA G3 APAP DEVICE. THE DME HAD BEEN CONTACTED BY THE PATIENT'S REHAB

  Patient problems: Insufficient Information

  MAUDE report 24197303 ↗
• MalfunctionNov 23, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  REACT HEALTH RECEIVED A COMPLAINT FROM A DURABLE MEDICAL EQUIPMENT PROVIDER THAT A PATIENT STATED HIS MACHINE LOST SOME POWER AND HE WOKE UP SEVERAL TIMES WITH SHORTNESS OF BREATH. HIS BLOOD PRESSURE WAS 181/101 (HYPERTENSIVE CRISIS/URGENCY) AND HIS HAND WAS ICE COLD. THE PATIENT DID NOT SEEK MEDICAL ATTENTION. THE MANUFACTURER HAS RECEIVED THE DEVICE AND INVESTIGATED.

  Patient problems: Alteration in Body Temperature; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bronchial Hemorrhage; High Blood Pressure/ Hypertension

  MAUDE report 23628032 ↗
• InjuryOct 17, 2025Output Problem; Output Problem

  3B MEDICAL, INC. DBA REACT HEALTH WAS CONTACTED BY A DURABLE MEDICAL EQUIPMENT (DME) PROVIDER ADVISING THAT THEIR PATIENT REPORTED THAT OVER THE LAST FEW WEEKS HE'S BEEN WAKING UP WITH INCREASED BLOOD PRESSURE AND "FEELINGS OF SUFFOCATION¿ USING THE DEVICE. THE DME PROVIDER ADVISED REACT HEALTH THAT HE HAD REVIEWED THE DATA FROM THE PATIENT¿S DEVICE AND NOTICED INCREASES IN PRESSURE, BUT THERE WERE NO APPARENT OBSTRUCTIONS OCCURRING (OR AT LEAST NOTHING BEING RECORDED BY THE DEVICE). ADDITIONALLY, HE ADVISED THAT THE LEAK LEVEL WAS SHOWING NO DEVIATION AT ALL ¿ IT WAS AT 0. THE DEVICE WAS THEN RETURNED TO, AND EVALUATED BY, REACT HEALTH WHO VERIFIED THE REPORTED ISSUES THAT THE DEVICE WAS INCREASING IN PRESSURE AND THAT THE DATA WAS NOT BEING RECORDED. DURING TESTING, REACT HEALTH ALSO OBSERVED THAT THE FLOW WAS ABNORMALLY LOW. REACT HEALTH DETERMINED THAT THE ROOT CAUSE OF THE REPORTED ISSUES WAS THE FLOW SENSOR ON THE MAIN PCBA. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER.

  Patient problems: Dyspnea; High Blood Pressure/ Hypertension

  MAUDE report 23326312 ↗
• MalfunctionSep 8, 2024Thermal Decomposition of Device; Device Emits Odor; Sparking; Thermal Decomposition of Device; Device Emits Odor; Sparking

  REACT HEALTH RECEIVED A COMPLAINT FROM A DURABLE MEDICAL EQUIPMENT PROVIDER STATING A PATIENT REPORTED THAT THE POWER SUPPLY ON THEIR CPAP SPARKED AND CREATED A BURNING SMELL. PATIENT REPORTED THAT THE POWER BRICK PORTION OF THE POWER CORD WAS HOT AND THE PLASTIC HOUSING HAD MELTED. THERE IS NO HARM OR INJURY REPORTED. THE DEVICE HAS BEEN RETURNED TO THE IMPORTER. THE MANUFACTURER HAS RECEIVED THE DEVICE AND INVESTIGATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20165838 ↗
• MalfunctionJun 24, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  REACT HEALTH RECEIVED A COMPLAINT FROM A DURABLE MEDICAL PROVIDER STATING THAT A DEVICE HAD EVIDENCE OF MELTING WHERE POWER CORD PLUGS IN. THE DEVICE HAS BEEN RECEIVED BY REACT HEALTH.THE MANUFACTURER HAS RECEIVED THE DEVICE AND INVESTIGATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19592234 ↗
• MalfunctionJun 12, 2024Device Emits Odor; Device Emits Odor

  REACT HEALTH RECEIVED A COMPLAINT FROM A DURABLE MEDICAL EQUIPMENT PROVIDER STATING THAT A DEVICE HAD A BURNING SMELL. THERE WAS NO PATIENT HARM OR INJURY REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. A FOLLOW UP REPORT WILL BE FILED ONCE THE INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19525644 ↗
• MalfunctionJun 4, 2024Device Emits Odor; Device Emits Odor

  REACT HEALTH RECEIVED A COMPLAINT FROM A DURABLE MEDICAL EQUIPMENT PROVIDER STATING THAT A DEVICE HAD A BURNING SMELL.THERE WAS NO PATIENT HARM OR INJURY REPORTED.THE DEVICE HAS BEEN RETURNED TO THE IMPORTER BUT THE MANUFACTURER HAS NOT TAKEN POSSESSION.A FOLLOW UP REPORT WILL BE FILED ONCE THE INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19456822 ↗
• MalfunctionMay 26, 2024Device Emits Odor; Device Emits Odor

  REACT HEALTH RECEIVED A COMPLAINT FROM A DURABLE MEDICAL EQUIPMENT PROVIDER STATING THAT THE PRESSURE WAS PULSING AND THE DEVICE WAS EMITTING A BURNING SMELL. NO PATIENT HARM OR INJURY WAS REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE IMPORTER. A FOLLOW UP REPORT WILL BE FILED ONCE THE INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19398863 ↗