Philips RespironicsRecalls & reported problems across all models

We found 3 models of Philips Respironics by Respironics California, Inc. in the FDA's device registry (GUDID). Together they are named in 13,623 adverse event reports in the FDA's MAUDE database, received between Apr 22, 2015 and Sep 30, 2026 — classified as 30 deaths, 101 injuries, 13,492 malfunctions.

The most frequently reported specific device problem is “Inadequate User Interface” (1,898 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 Respironics 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. 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 · Recall details · FDA record ↗

2. Jan 24, 2022Open, Classified

   A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially damage the capacitors, which could cause the ventilator to stop providing ventilation to the patient. This failure may either activate both visual and audible alarms, or it may not sound or display an alarm (a silent shutdown).

   Z-0662-2022 · Root cause: Process control · 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 · Recall details · FDA record ↗

Most reported Philips Respironics problems

Philips Respironics models

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

• Philips Respironics V60

  Ventilator, Continuous, Minimal Ventilatory Support,Facility Use
  3 recalls30 deaths13,525 reports
• Philips Respironics V60

  Ventilator, Continuous, Minimal Ventilatory Support,Facility Use
  73 reports
• Philips Respironics V60

  Ventilator, Continuous, Minimal Ventilatory Support,Facility Use
  25 reports

Recent Philips Respironics adverse event reports

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

• MalfunctionSep 30, 2026Failure to Shut Off

  Philips received a complaint by an Authorized Service Provider (ASP) on the V60 indicating a device malfunction as the device failed to turn on and off and needed to have the front bezel replaced. There was no patient involvement at the time the issue was discovered. No patient or user harm was reported.The ASP performed annual Preventive Maintenance (PM) and confirmed that the device could not be powered on and off as the ON/OFF switch was not working. No accessories, including third-party devices, were being used that may have contributed to the issue. The ASP performed a complete Performance Verification Test (PVT) per the manufacturer's specifications, checked the settings and event logs, and concluded that the issue originated from a faulty front bezel.Ultimately, the ASP replaced the front bezel and User Interface (UI) to Power Management (PM) cable, after which the issue was resolved. After installed the replacement parts, the ASP performed PVT, verified that the device passed all tests and calibrations and returned the device to service. The investigation concludes that no further action is required at this time. If additional information is received, the complaint file wil

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946358 ↗
• MalfunctionSep 29, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933056 ↗
• MalfunctionSep 29, 2026Mechanical Problem

  The Biomedical Engineer (BME) reported that the V60 Ventilator stand had a broken locking caster. 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.A Philips Remote Service Engineer (RSE) provided assistance to the BME, and it was reported that the issue was replicated during diagnostics. The BME was provided with the part numbers (locking casters, and caster wrench) for replacement parts. The issue was replicated/confirmed during diagnostics. Based on the details provided, the damaged castors are considered a malfunction and can become a stability issue for the device. This investigation is ongoing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931993 ↗
• MalfunctionSep 29, 2026Tidal Volume Fluctuations

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931305 ↗
• MalfunctionSep 25, 2026Device Sensing Problem

  Philips received a complaint by the customer on the V60 indicating a device malfunction as the device had a ventilator (vent) inoperative (INOP); a 1009 "Pressure regulation high" error was present. It was reported that there was no patient involvement at the time the issue was discovered. No patient or user harm was reported. The device was removed from service.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.The customer called technical support to report that the device had a vent INOP with a 1009 "Pressure regulation high" error. The Remote Service Engineer (RSE) performed troubleshooting with the customer, but the 1009 error could not be duplicated. The RSE reviewed the suggested repair for the 1009 error with the customer according to the V60 service manual and verified that the Proximal and Machine pressure lines were routed correctly. The RSE also advised the customer to perform Performance Verification Test (PVT) testing (specifically pressure testing) and address any issues found. The customer informed the RSE that the air Inlet filter was replaced but app

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896795 ↗
• MalfunctionSep 25, 2026Excessive Heating

  Philips received a complaint by the customer on the V60 indicating a device malfunction as the device had a high temperature blower motor error. It was reported that there was no patient involvement at the time the issue was discovered. No patient or user harm was reported.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.The customer called technical support to report a "blower temperature high" alarm error. No accessories, including third-party devices, were being used that may have contributed to the issue. The customer checked the event log but was unable to verify the error in the event log. After powering on the device in normal operational mode and letting it run for over 30 minutes, the customer did not discover any alarms. The Remote Service Engineer (RSE) informed the customer of the recommended repair per the V60 service manual if the high blower temperature error reoccurs. The customer noted that further testing will be performed. This investigation is ongoing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896793 ↗
• MalfunctionSep 24, 2026Inadequate User Interface

  Philips received a complaint by a Biomedical Engineer (BME) on the V60 indicating a device malfunction as touchscreen calibration failed. There was no patient involvement at the time the issue was discovered as the issue occurred during Preventive Maintenance (PM). No patient or user harm was reported. 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. A Biomedical Engineer (BME) discovered that touchscreen calibration failed during Preventive Maintenance (PM) and found that the replacement touchscreen needed to be ordered. Upon receiving the replacement touchscreen, the BME replaced the defective touchscreen and performed the Extended Self-Test (EST), after which the issue was resolved. The touchscreen replacement indicates that the cause of the malfunction was ultimately due to a faulty touchscreen replacement that needed to be replaced for repair. The device passed the required Performance Verification tests per Philips standard and was returned to service. No other malfunction was found. The investigation concludes that no further action is required at this time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884067 ↗
• MalfunctionSep 21, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50840378 ↗
• MalfunctionSep 17, 2026Failure to Sense

  The customer reported that the V60 Ventilator displayed a "Machine and Proximal Pressure Sensors Failed" error code (1007). 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 customer inquired about the part number for a replacement Data Acquisition (DA) to Motor Controller (MC) cable; during the call, there was no allegation of malfunction reported. A follow up was performed with the customer, and it was reported that the device displayed a "Machine and Proximal Pressure Sensors Failed" error code (1007). It was reported that the Data Acquisition (DA) board, and Gas Delivery System (GDS) were replaced for preventative maintenance; after replacement of the parts, the customer saw the error code. The customer attempted to replace the DA to motor controller (MC) cable, but the issue was not resolved. The old DA board was then reinstalled, and the issue was resolved. It was determined that the replacement DA board was defective out of box (DEFOA). The issue was replicated/confirmed by the customer. The customer reported that the old DA board was reinstalled to fix the issue. It was noted tha

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805919 ↗
• MalfunctionSep 3, 2026Inadequate User Interface

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50596350 ↗
• MalfunctionAug 27, 2026Unintended Power Up

  A Biomedical Engineer (BME) reported that a V60 ventilator powered on by itself without patient involvement, resulting in no patient or user impact or harm. A Philips Remote Service Engineer (RSE) assisted with troubleshooting, during which the uncommanded power-on issue was successfully replicated and confirmed. The RSE mapped out the power switch electrical circuit path¿encompassing the power switch overlay, the user interface (UI) assembly printed circuit board assembly (PCBA), and the power management (PM) PCBA¿and advised the BME to isolate the system by disconnecting the battery. When tested strictly on alternating current (AC) power, the BME reported that the device no longer powered on by itself. The RSE then instructed the BME to monitor the ventilator for several hours on AC power; if the issue does not recur, the battery should be replaced, but if the auto-power behavior returns, the BME must trace the previously discussed signal path. The BME was provided with the part number for a replacement battery, and the final investigation and disposition remain pending.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50479711 ↗
• MalfunctionAug 18, 2026Display or Visual Feedback Problem

  Philips received a complaint by the customer on the V60 indicating a device malfunction as the screen was not working properly. There was no patient involvement at the time the issue was discovered as the issue occurred during Preventive Maintenance (PM) evaluation. No patient or user harm was reported.The customer called technical support to report that the Liquid Crystal Display (LCD) assembly, NEC LCD cable, User Interface (UI) Printed Circuit Board Assembly (PCBA) to LCD cable, UI PCBA, and LCD tray needed to be ordered. Per the customer communication on (b)(6)2026, the parts were used to address an improperly working screen. The V60 service manual (Revision T) was used in diagnosing the issue. Once the LCD assembly, NEC LCD cable, UI PCBA to LCD cable, UI PCBA, and LCD tray were replaced, the issue was resolved as the device operated as intended per the manufacturer's specifications. The device passed the required Performance Verification tests per Philips standard and was returned to service. No other malfunction was found. 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 50304332 ↗
• MalfunctionJul 6, 2026Tidal Volume Fluctuations

  PHILIPS RECEIVED A CUSTOMER COMPLAINT REGARDING A V60 VENTILATOR MALFUNCTION WHERE THE DEVICE FAILED TO SENSE ANY PATIENT VOLUMES. AT THE TIME OF THE EVENT, THE DEVICE WAS ACTIVELY IN USE ON A PATIENT, BUT NO HARM TO THE PATIENT OR USER WAS REPORTED. THE DEVICE WAS PROMPTLY TAKEN OUT OF SERVICE, AND THE CUSTOMER CONTACTED TECHNICAL SUPPORT TO REPORT THE VOLUME SENSING ISSUE. THE USER ENCOUNTERED NO ERROR CODES OR ERROR MESSAGES DURING THE EVENT, AND NO ACCESSORIES OR THIRD-PARTY DEVICES CONTRIBUTED TO THE PROBLEM. A REMOTE SERVICE ENGINEER (RSE) PERFORMED TROUBLESHOOTING WITH THE CUSTOMER AND CONFIRMED THE ISSUE. BECAUSE THE DEVICE WAS UNDER CONTRACT, THE CUSTOMER REQUESTED ONSITE SERVICE. IN RESPONSE, THE RSE PROVIDED THE CUSTOMER WITH A BENCH REPAIR DOCUMENT AND CREATED A WORK ORDER TO DISPATCH AN AUTHORIZED SERVICE PROVIDER (ASP) TO EVALUATE AND REPAIR THE MACHINE ONSITE.UPON ARRIVING ONSITE, THE ASP REPLICATED THE REPORTED ISSUE AS SOON AS THEY POWERED ON THE DEVICE, OBSERVING THAT THE SCREEN FAILED TO SHOW PROPER DATA VALUES AND INSTEAD DISPLAYED ONLY ASTERISKS. TO TROUBLESHOOT, THE ASP ATTACHED A LUNG TESTING KIT AND CONFIRMED THAT THE DEVICE WAS NOT READING ANY VOLUME VALUES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25724913 ↗
• MalfunctionJul 1, 2026No Display/Image

  PHILIPS RECEIVED A PRODUCT COMPLAINT REGARDING A V60 VENTILATOR THAT PRESENTED WITH A BLANK DISPLAY WHILE OUTSIDE OF CLINICAL USE. NO PATIENT OR USER HARM OCCURRED AS A RESULT OF THIS ISSUE. THE CUSTOMER REPORTED TO A REMOTE SERVICE ENGINEER (RSE) THAT WHILE THE DEVICE SUCCESSFULLY POWERED ON, THE SCREEN REMAINED COMPLETELY BLANK AND UNREADABLE. THE RSE ADVISED THAT THE FACILITY COULD EITHER REPLACE THE ENTIRE USER INTERFACE (UI) ASSEMBLY OR ORDER INDIVIDUAL UI COMPONENTS, AND SUBSEQUENTLY PROVIDED THE REQUESTED PART NUMBERS FOR THE FULL ASSEMBLY. THE OFFICIAL INVESTIGATION INTO THE ROOT CAUSE OF THE DISPLAY FAILURE REMAINS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25678845 ↗
• MalfunctionJun 30, 2026Inadequate User Interface

  PHILIPS RECEIVED A COMPLAINT BY A BIOMEDICAL ENGINEER (BME) ON THE V60 (SOFTWARE VERSION 3.10) INDICATING THAT THE LIQUID CRYSTAL DISPLAY (LCD) NEEDED TO BE REPLACED. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. NO PATIENT OR USER HARM WAS REPORTED. AS OF JUNE 15, 2026, AN AUTHORIZED SERVICE PROVIDER (ASP) WAS DISPATCHED ONSITE TO EVALUATE AND REPAIR THE DEVICE, AND UPON ARRIVAL, THE ASP PERFORMED TEST AND VERIFICATION (T&V) TESTS PER THE V60 SERVICE MANUAL AND CALIBRATED LCD SCREEN. THE ASP FOUND THAT THE LIQUID CRYSTAL DISPLAY (LCD) WAS NOT FUNCTIONING; HOWEVER, THE TOUCHSCREEN WAS ABLE TO BE CALIBRATED AND RECOGNIZE TOUCHES. NO ERROR CODES/ERROR MESSAGES WERE ENCOUNTERED BY THE USER, AND NO ACCESSORIES, INCLUDING THIRD-PARTY DEVICES, WERE BEING USED THAT MAY HAVE CONTRIBUTED TO THE ISSUE. ULTIMATELY, THE ASP FOUND THAT THE CAUSE OF THE MALFUNCTION WAS DUE TO A FAULTY NEC LCD CABLE THAT NEEDED TO BE REPLACED FOR REPAIR; AFTER PERFORMING THE REPLACEMENT, THE ASP VERIFIED THAT THE ISSUE WAS RESOLVED. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25669536 ↗

Other Respironics California, Inc. products

• PHILIPS6 models · 6,617 reports · 3 recalls