PHILIPSRecalls & reported problems across all models

We found 6 models of PHILIPS by Respironics California, Inc. in the FDA's device registry (GUDID). Together they are named in 6,617 adverse event reports in the FDA's MAUDE database, received between Nov 14, 2016 and Sep 29, 2026 — classified as 14 deaths, 60 injuries, 6,543 malfunctions.

The most frequently reported specific device problem is “Inadequate User Interface” (1,314 reports).

3 FDA recall records name at least one of these models by its device identifier, 3 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. 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

PHILIPS recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 15, 2023Open, Classified

   Devices were imported with Japanese Language and NIST Oxygen Gas Fittings and retrofitted, may pose a serious health risk as the gas pathway of these devices may be contaminated.

   Z-2025-2023 · Root cause: No Marketing Application · Recall details · FDA record ↗

2. Feb 28, 2022Open, Classified

   Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate.

   Z-0907-2022 · Root cause: Device Design · names 3 of these models · Recall details · FDA record ↗

3. Jun 18, 2021Open, Classified

   It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 and 3.10), that includes a designed safety mechanism that limits the amount of pressure that can be delivered to a patient, in situations where the system pressure reaches the maximum limit and sounds the "Cannot Reach Target Flow" alarm , the system will reduce pressure and simultaneously decreasing the flow rate to a level below what was set by the clinicians. If the reason for the increase in pressure is not resolved, the ventilator will continue to provide the lower flow rate, which result in patients experiencing oxygen desaturation which can be characterized as moderate or severe hypoxemia.

   Z-2073-2021 · Root cause: Device Design · names 3 of these models · Recall details · FDA record ↗

Most reported PHILIPS problems

PHILIPS models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• PHILIPS 1076716

  Ventilator, continuous, minimal ventilatory support, facility use
  2 recalls1 death2,946 reports
• PHILIPS 1076709

  Ventilator, continuous, minimal ventilatory support, facility use
  8 deaths2,174 reports
• PHILIPS 1053614

  Ventilator, continuous, minimal ventilatory support, facility use
  2 recalls4 deaths1,203 reports
• PHILIPS 1053613

  Ventilator, continuous, minimal ventilatory support, facility use
  2 recalls1 death161 reports
• PHILIPS 1053615

  Ventilator, continuous, minimal ventilatory support, facility use
  1 recall132 reports
• PHILIPS 1076374

  Ventilator, continuous, minimal ventilatory support, facility use
  1 report

Recent PHILIPS adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934805 ↗
• MalfunctionSep 29, 2026Complete Loss of Power

  The customer reported that the V60 Ventilator displayed a "35V power supply fault" message. It was unknown how the issue was found. No patient impact and/or harm was reported. No user impact and/or harm was reported. It was reported that the V60 Ventilator displayed a "35V power supply fault" message. No testing was reported to have been performed to replicate the issue and/or determine the cause. The issue was confirmed by the customer. No testing was reported to have been performed by the customer. It was reported that the driver board was replaced to resolve the issue. The customer reported that the device was returned to normal. The investigation concludes that no further action is required at this time. If additional information is received the complaint file will be reopened.Based on the details provided, a malfunction occurred, and the device displayed a "35V power supply failure" message. The cause of the malfunction was determined to be a failure in the driver board. A conclusion/root cause can not be provided at this time, as the suspected part has not been returned for further analysis. In the event the suspected part is received, the evaluation will be performed, and th

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931868 ↗
• MalfunctionSep 29, 2026Inadequate User Interface

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931546 ↗
• MalfunctionSep 28, 2026Fitting Problem

  The Biomedical Engineer (BME) reported that the V60 Ventilator had an oxygen hose that had "fallen off." There was no patient involvement when the issue occurred. No patient impact and/or harm was reported. No user impact and/or harm was reported.The BME reported that the oxygen hose had "fallen off;" no further details were provided regarding the event. Per the diagnostics performed by an Engineer, the issue was not replicated. It was noted that a Philips Field Service Engineer (FSE) would be dispatched, and an evaluation would be performed. It was noted that the integrity of the ventilator support would be checked, and that a top assembly may be ordered. The issue was not replicated during diagnostics. This investigation is ongoing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914708 ↗
• MalfunctionSep 28, 2026Failure to Sense

  On 16Sep2026, Philips received a complaint from the Second Provincial General Hospital of Guangdong Province on the V60 indicating a device malfunction as the device issued a "Proximal pressure sensor autozero failed" alarm while the department was preparing to use this ventilator. It was reported that there was no patient involvement at the time the issue was discovered. No patient or user harm was reported. Normal operation resumed after the device was replaced.Based on the case information provided, the device did not meet product specifications. The alleged malfunction impacted the user¿s ability to use the device properly. This investigation is ongoing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914316 ↗
• MalfunctionSep 17, 2026Inaccurate Delivery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50808396 ↗
• MalfunctionSep 14, 2026Inadequate User Interface

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50760738 ↗
• MalfunctionSep 8, 2026Complete Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50675876 ↗
• MalfunctionSep 8, 2026Complete Loss of Power

  Philips received a complaint on the V60 ventilator indicating that there was a 35 Volt (V) power supply failure. It is unknown if the device was in use at the time of the reported problem. No patient or user harm reported. This investigation is ongoing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50670157 ↗
• MalfunctionAug 24, 2026Unexpected Shutdown

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50418108 ↗
• MalfunctionAug 18, 2026Device Alarm System

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50308368 ↗
• MalfunctionJul 27, 2026Tidal Volume Fluctuations

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50007769 ↗
• MalfunctionJul 7, 2026Inadequate User Interface

  PHILIPS RECEIVED A COMPLAINT BY A FIELD SERVICE TECHNICIAN ON THE V60 INDICATING A DEVICE MALFUNCTION AS THERE WAS A MISALIGNMENT IN THE TOUCH POSITION. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. NO PATIENT OR USER HARM WAS REPORTED. A FIELD SERVICE TECHNICIAN PERFORMED REGULAR MAINTENANCE ON THE DEVICE AND CONFIRMED THAT THERE WAS A TOUCHSCREEN MISALIGNMENT--THE FIELD SERVICE TECHNICIAN CALIBRATED THE TOUCHSCREEN, BUT THE ISSUE REMAINED. THEREFORE, THE FIELD SERVICE TECHNICIAN ULTIMATELY REPLACED THE TOUCHSCREEN, AFTER WHICH THE ISSUE WAS RESOLVED. THE TOUCHSCREEN REPLACEMENT INDICATES THAT THE CAUSE OF THE MALFUNCTION WAS DUE TO A FAULTY TOUCHSCREEN THAT NEEDED TO BE REPLACED FOR REPAIR. FOLLOWING THE TOUCHSCREEN REPLACEMENT, THE FIELD SERVICE TECHNICIAN CONFIRMED THAT SOFTWARE VERSION 3.20 WAS INSTALLED, CONDUCTED A COMPREHENSIVE INSPECTION, CLEANED THE DEVICE, PERFORMED RUNNING AND FUNCTIONAL TESTING, AND RETURNED THE DEVICE TO SERVICE AS THE DEVICE PASSED THE REQUIRED PERFORMANCE VERIFICATION TESTS PER PHILIPS STANDARD. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25734751 ↗
• MalfunctionJul 6, 2026Failure to Charge

  PHILIPS RECEIVED A CUSTOMER COMPLAINT REGARDING A V60 VENTILATOR INDICATING THAT THE INTERNAL BATTERY WAS DEFECTIVE AND COULD NOT HOLD A CHARGE. ON (B)(6) 2026, THE CUSTOMER STATED THAT THE DEVICE WOULD SHUT DOWN IMMEDIATELY WHENEVER IT WAS DISCONNECTED FROM THE ALTERNATING CURRENT (AC) POWER SUPPLY. NO PATIENT OR USER HARM WAS REPORTED, AND THE DEVICE WAS CONFIRMED TO BE OUTSIDE OF USE AT THE TIME THE PROBLEM OCCURRED. IN RESPONSE, A GOOD FAITH EFFORT (GFE) COMMUNICATION WAS RECEIVED FROM THE AUTHORIZED SERVICE PROVIDER (ASP). WHILE THE ASP DID NOT PROVIDE THE DIAGNOSTIC REPORT (DRPT) FROM THE TIME OF THE EVENT, THEY CLARIFIED THAT THE NECESSARY SERVICE HAS SINCE BEEN COMPLETED. THE ASP STATED THAT THE SPECIFIC INFORMATION FOR THE PARTS USED TO SERVICE THE DEVICE WAS ASKED BUT UNKNOWN (ASKU). HOWEVER, THE ASP CONFIRMED THAT THE DEVICE WAS SUCCESSFULLY RESTORED TO FULL FUNCTIONALITY AND HAS BEEN RETURNED TO ACTIVE HOSPITAL USE. THE INVESTIGATION CONFIRMS THAT A PRODUCT MALFUNCTION OCCURRED, BUT THE EXACT ROOT CAUSE COULD NOT BE DETERMINED BECAUSE THE SPECIFIC SERVICE PART INFORMATION WAS NOT PROVIDED. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME, AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25724911 ↗
• MalfunctionJul 1, 2026Inadequate User Interface

  WHILE SERVICING THE DEVICE, THE SE REPORTED THAT THERE WAS A MISALIGNMENT IN THE TOUCH POSITION. A TOUCHSCREEN CALIBRATION WAS PERFORMED, BUT THE ISSUE WAS NOT RESOLVED. THERE WAS NO PATIENT INVOLVEMENT WHEN THE ISSUE OCCURRED. NO PATIENT IMPACT AND/OR HARM WAS REPORTED. THE SE REPLACED THE TOUCHSCREEN TO RESOLVE THE ISSUE. THE DEVICE WAS CHECKED, CLEANED, AND TESTED; THE DEVICE WAS THEN RETURNED TO THE CUSTOMER, READY FOR SERVICE. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25679060 ↗

Other Respironics California, Inc. products

• Philips Respironics3 models · 13,623 reports · 3 recalls