SimplyGoRecalls & reported problems across all models
Respironics, Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 155
- Deaths reported
- 10
- Injuries reported
- 10
- Recalls
- 0
We found 5 models of SimplyGo by Respironics, Inc. in the FDA's device registry (GUDID). Together they are named in 155 adverse event reports in the FDA's MAUDE database, received between Mar 2, 2017 and Sep 24, 2026 — classified as 10 deaths, 10 injuries, 135 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (47 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported SimplyGo problems
Device problems
- Overheating of Device47
- Thermal Decomposition of Device33
- Excessive Heating15
- Battery Problem11
- Melted10
- Adverse Event Without Identified Device or Use Problem9
- Device Operational Issue6
- Temperature Problem6
Patient problems
- No Clinical Signs, Symptoms or Conditions138
- Insufficient Information6
- Low Oxygen Saturation6
- Dyspnea2
- No Code Available2
- Patient Problem/Medical Problem2
- Cardiac Arrest1
- Death1
SimplyGo models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SimplyGo SimplyGo, FRGenerator, oxygen, portable52 reports
- SimplyGo SimplyGo, BRGenerator, oxygen, portable44 reports
- SimplyGo SimplyGo, USGenerator, oxygen, portable10 deaths29 reports
- SimplyGo SimplyGo, INTLGenerator, oxygen, portable29 reports
- SIMPLYGO SimplyGo, INTL, ITGenerator, oxygen, portable1 report
Recent SimplyGo adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Thermal Decomposition of Device
The device was sent to a third-party service center for investigation. During evaluation, the debug technician noticed that the PCA has a burnt resistor. Due to the alleged malfunction, the device will be forwarded to the manufacturer¿s Product Investigation Lab (PIL) for additional testing and investigation. A final report will be sent once the investigation is concluded.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890105 ↗MalfunctionSep 3, 2026Melted
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50598361 ↗MalfunctionAug 12, 2026Thermal Decomposition of Device
The SimplyGo device was sent to a third-party service center for investigation. During evaluation, the third-party service center found a Printed Circuit Assembly (PCA) burnt. Due to the alleged malfunction, the device will be forwarded to the manufacturer for additional testing and investigation. A final report will be sent once the investigation is concluded.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50225596 ↗MalfunctionJul 14, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25819504 ↗MalfunctionJun 2, 2026Overheating of Device
A SIMPLYGO DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION WITH ALLEGATIONS THAT THE LIGHT WON'T TURN ON ANYMORE. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED THAT THE UNIT HAD COME WITH THE LIGHT WON'T TURN ON ANYMORE BECAUSE THE PCA WAS BURNED. ADDITIONALLY, UNRELATED TO THE REPORTABLE MALFUNCTION, THE TECHNICIAN OBSERVED SIEVES WERE CLOGGED, INLET FILTER NEEDS TO BE REPLACED DUE TO PREVENTIVE MAINTENANCE, CHECK VALVE WAS CRACKED, CABLE TIES NEED REPLACEMENT, FLEXCABLE AND FRONT ENCLOSURE ARE BURNED. THESE PARTS NEED REPLACEMENT. THE DEVICE WAS REPAIRED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25366108 ↗MalfunctionMay 20, 2026Overheating of Device
A SIMPLYGO, INTERNATIONAL, IT DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. DURING THE EVALUATION OF THE DEVICE, THE THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND FOUND THAT THE PCA IS BURNT. SIEVES ARE CLOGGED; THEY HAVE TO BE REPLACED. INLET FILTER WILL BE REPLACED DUE TO PREVENTIVE MAINTENANCE. COMPRESSOR IS DEFECTIVE, IT HAS TO BE REPLACED. TUBING IS CONTAMINATED; IT HAS TO BE REPLACED. CHECK VALVE COVER IS CRACKED, IT HAS TO BE REPLACED. THERE ARE MISSING SCREWS ON THE REAR ENCLOSURE; THEY HAVE TO BE ADDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25237595 ↗MalfunctionApr 24, 2026Overheating of Device
A SIMPLYGO DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH INITIAL ALLEGED COMPLAINT OF BURNING SMELL, DEVICE SHUT OFF AND WON'T TURN BACK ON. DURING EVALUATION, THE SERVICE CENTER FOUND THAT PCA IS BURNED AND REQUIRES REPLACEMENT, INLET FILTER MUST BE REPLACED DUE TO PREVENTIVE MAINTENANCE. ADDITIONALLY, THE DEVICE WAS RETURNED REPAIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24987777 ↗MalfunctionApr 23, 2026Degraded
THIS NOTIFICATION WAS OPENED FOR REVIEW FOR INFORMATION RECEIVED THAT THE SIMPLY GO DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH AN ALLEGATION OF SMELL OF BURNING. DURING THE EVALUATION OF THE DEVICE, THE THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND FOUND THAT THE PCA WAS BURNT, IT HAS TO BE REPLACED AND SIEVES WERE CLOGGED, THEY HAVE TO BE REPLACED. IN ADDITION, INLET FILTER WILL BE REPLACED DUE TO PREVENTIVE MAINTENANCE, THE COMPRESSOR WAS DEFECTIVE, IT HAS TO BE REPLACED, AND CHECK VALVE COVER WAS CRACKED, IT HAS TO BE REPLACED. THE DEVICE HAS BEEN FORWARDED TO THE MANUFACTURER¿S PRODUCT INVESTIGATION LAB (PIL) FOR ADDITIONAL TESTING AND INVESTIGATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24973902 ↗MalfunctionApr 20, 2026Overheating of Device
THE MANUFACTURER WAS CONTACTED IN REFERENCE TO A SIMPLY GO DEVICE. THERE WAS AN ALLEGATION OF ALARMING, FILTER WAS MELTED AND THAT THE SIEVE CANISTER, INLET FILTER KIT WAS REPLACED. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24924329 ↗MalfunctionApr 10, 2026Electrical /Electronic Property Problem; Excessive Heating
THE DEVICE WAS SENT TO A THIRD-PARTY SERVICE CENTER FOR INVESTIGATION. DURING EVALUATION, THE THIRD-PARTY SERVICE CENTER FOUND A BURNT PCA. DUE TO THE ALLEGED MALFUNCTION, THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER¿S PRODUCT INVESTIGATION LAB (PIL) FOR ADDITIONAL TESTING AND INVESTIGATION. A FINAL REPORT WILL BE SENT ONCE THE INVESTIGATION IS CONCLUDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24844298 ↗DeathApr 10, 2026Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER RECEIVED INFORMATION IN REGARD TO A USER OF A SIMPLYGO DEVICE HAS PASSED AWAY. THE MANUFACTURER RECEIVED INFORMATION ALLEGING DEATH; HOWEVER, THERE IS NO INFORMATION THAT THE DEATH IS RELATED TO THE DEVICE. MEDICAL INTERVENTION WAS NOT SPECIFIED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: Insufficient Information
MAUDE report 24840650 ↗MalfunctionApr 9, 2026Overheating of Device
A SIMPLYGO DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE WITH ALLEGATION OD OUT OF BOX FAILURE. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, DURING EVALUATION THE DEBUG TECHNICIAN NOTICED THAT THE PCA HAD A THERMAL EVENT. THE DEVICE WAS NOT REPAIRED AT THIRD PARTY SERVICE CENTER. DEVICE SENT TO MANUFACTURER PRODUCT INVESTIGATION LABORATORY FOR FURTHER INVESTIGATION. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24832713 ↗MalfunctionApr 8, 2026Excessive Heating
A SIMPLYGO DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION. DURING THE EVALUATION IT WAS NOTED THAT THE DEVICE HAD A BURNT PCA. ADDITIONAL FINDINGS INCLUDED CLOGGED SIEVES AND A DEFECTIVE, NOISY COMPRESSOR THAT REQUIRED REPLACEMENT. THE INLET FILTER WAS ALSO REPLACED DUE TO PREVENTIVE MAINTENANCE. DUE TO THE ALLEGED MALFUNCTION, THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER¿S PRODUCT INVESTIGATION LAB (PIL) FOR ADDITIONAL TESTING AND INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24824575 ↗MalfunctionApr 7, 2026Overheating of Device; Power Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING BURNING SMELL. THE UNIT WAS SWAPPED FOR ANOTHER DEVICE AND CONFIRMED THAT THE CUSTOMER ALSO DETECTED A BURNING ODOR AND TAGGED AS "OUT OF SERVICE" AND PLACED ON WORKBENCH. CUSTOMER ATTEMPTED TO POWER ON THE DEVICE USING THE AC ADAPTER BUT THE UNIT DID NOT RESPOND BUT NOTICED THE GREEN LIGHT ON THE ADAPTER WAS FLASHING RATHER THAN REMAINING SOLID. CUSTOMER STATED THEY TRIED TO POWER THE UNIT USING A FULLY CHANGED BUTTER BUT FAILED TO TURN ON. CONTACTED THE REPAIR CENTER REGARDING THEIR ISSUES AND SUGGESTED A POSSIBLE THERMAL EVENT AND A FAULTY PC BOARD. THERE WAS NO PATIENT HARM OR INJURY REPORTED WITH THIS NOTIFICATION. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER PRODUCT INVESTIGATION LABORATORY (PIL) FOR EVALUATION, PIL ABLE TO CONFIRM THE CUSTOMER ALLEGATION OF BURNING SMELL DUE TO THERMAL DAMAGE ON THE PCA. THE UNIT ARRIVED AT PIL WITHOUT BATTERY AND POWER SUPPLY. DURING THE INTERNAL INSPECTION IT WAS SHOWED A BLACK RESIDUE ON THE BACK ENCLOSURE (INDICATIVE OF A THERMAL EVENT ON THE PCA). THERMAL DAMAGE ON THE PCA (Q2 AND Q6), SIEVE CANS ARE THE ORIGINAL CANS FROM WHEN THE UNIT WAS MANUFACTURER. A DUST-LIKE CONTAMINATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24806900 ↗MalfunctionApr 1, 2026Overheating of Device
A SIMPLYGO DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED PCA BURN MARKS WAS OBSERVED. ADDITIONALLY, SIEVES AND INLET FILTER PREVENTIVE MAINTENANCE, COMPRESSOR DEFECTIVE AND THE PATIENT'S COMPLAINT ABLE TO REPRODUCE, CONTAMINATION WAS OBSERVED AND THE DEVICE WAS SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24758608 ↗
Other Respironics, Inc. products
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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