PHILIPS 1053614Recalls & reported problems
Respironics California, Inc. · V60 Ventilator,Intl Opt: CFLEX,AVAPS · Class 2
All models of PHILIPS (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Philips ventilator has 1,206 adverse event reports, including 4 deaths and 10 injuries. Many reports describe a confusing user interface, and others describe battery and power problems, sensing faults, and alarm faults. Some describe broken touchscreens, keypads, or power cords. There are 2 open recalls: one about an internal electrical circuit that can make the ventilator stop operating, and one about a High Flow Therapy software issue. Reports in the last 12 months (80) are fewer than in the 12 months before (128).
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 1,203
- Deaths reported
- 4
- Injuries reported
- 10
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 1,203 adverse event reports that list this exact device (DI 00884838009851), received between Dec 15, 2016 and Sep 28, 2026 — classified as 4 deaths, 10 injuries, 1,189 malfunctions.
The most frequently reported specific device problem is “Inadequate User Interface” (303 reports).
2 FDA recall records name this device's identifier, 2 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 16, 2026.
Reports received per month
Recalls naming this device
- 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 ↗
- 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 problems
Device problems
- Inadequate User Interface303
- Battery Problem64
- Device Sensing Problem61
- Device Alarm System55
- Grounding Malfunction54
- Power Problem43
- Failure to Sense38
- Unexpected Shutdown36
Patient problems
- No Clinical Signs, Symptoms or Conditions985
- No Patient Involvement89
- Insufficient Information59
- No Known Impact Or Consequence To Patient56
- No Consequences Or Impact To Patient20
- Hypoxia7
- Apnea1
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 1,203 reports, in the reporter's own words as published by the FDA.
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 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 ↗MalfunctionAug 18, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50308368 ↗MalfunctionJun 22, 2026Inadequate User Interface
PHILIPS RECEIVED A COMPLAINT BY THE BIOMEDICAL ENGINEER (BME) ON THE V60 INDICATING A DEVICE MALFUNCTION AS THE KEYPAD WAS NOT WORKING. PER THE GOOD FAITH EFFORT (GFE) RESPONSE RECEIVED, THE DEVICE WAS NOT IN PATIENT USE AT THE TIME THIS ISSUE WAS DISCOVERED AND WAS IN STANDBY MODE. THE FIELD SERVICE ENGINEER (FSE) NOTED THAT THIS CASE WAS LOGGED BY A NEW BIOMEDICAL ENGINEER, WHO IS NOT FAMILIAR WITH OPERATING THE VENTILATOR. THE FSE PROVIDED THE BME WITH GUIDANCE PER VIDEO CALL AND ULTIMATELY DISCOVERED THAT THE DEVICE OPERATED AS INTENDED. IT WAS REPORTED THAT NO ISSUES WERE FOUND WITH THE VENTILATOR. 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 25579091 ↗MalfunctionJun 18, 2026Inadequate User Interface
PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT THERE WAS TOUCHSCREEN FAILURE. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. IT WAS REPORTED THAT THERE WAS TOUCHSCREEN FAILURE. NON-WARRANTY REPAIR WAS COMPLETED BY THE DISTRIBUTOR. IT WAS STATED THAT THE USER INTERFACE (UI) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) WAS REPLACED AND THE DEVICE PASSED TESTING AFTER. THE DISTRIBUTOR REPLACED THE UI PCBA TO RESOLVE THE REPORTED ISSUE. THE DEVICE PASSED REQUIRED PERFORMANCE VERIFICATION TESTS PER PHILIPS STANDARDS AND WAS RETURNED TO SERVICE. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED. THE ISSUE WAS DETERMINED TO BE A MALFUNCTION. THE REPORTED ISSUE OF TOUCHSCREEN FAILURE WAS CONFIRMED. NO INFORMATION ON HOW REPORTED ISSUE WAS CONFIRMED WAS PROVIDED. THE CAUSE OF THE MALFUNCTION WAS DUE TO A FAULTY UI PCBA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25546841 ↗MalfunctionJun 8, 2026Inadequate User Interface
PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING A DEVICE MALFUNCTION AS THE TOUCHSCREEN WAS NOT RESPONDING TO TOUCH CORRECTLY. 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. THE CUSTOMER CALLED TECHNICAL SUPPORT TO REPORT THAT THE TOUCHSCREEN WAS NOT RESPONDING TO TOUCH CORRECTLY; A "BAD TOUCH DETECTED" ERROR MESSAGE WAS DISPLAYED DURING CALIBRATION. THE REMOTE SERVICE ENGINEER PERFORMED TROUBLESHOOTING WITH THE CUSTOMER AND WAS ABLE TO REPLICATE THE REPORTED ISSUE. THE RSE ADVISED THE CUSTOMER THAT THE TOUCHSCREEN NEEDED TO BE REPLACED FOR REPAIR AND PROVIDED THE CUSTOMER WITH THE PART NUMBER OF THE REPLACEMENT TOUCHSCREEN FOR REPAIR. THE CUSTOMER WAS FAMILIAR WITH THE REPLACEMENT PROCEDURE. FINAL INVESTIGATION AND DISPOSITION ARE PENDING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25429053 ↗MalfunctionJun 5, 2026Failure to Sense
THE CUSTOMER REPORTED THAT THE V60 VENTILATOR DISPLAYED A "PROXIMAL LINE DISCONNECTION" MESSAGE. IT WAS UNKNOWN HOW THE ISSUE WAS FOUND. NO PATIENT IMPACT AND/OR HARM REPORTED. FINAL INVESTIGATION AND DISPOSITION ARE PENDING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25411490 ↗MalfunctionJun 3, 2026Unstable
THE CUSTOMER REPORTED THAT THE TRANSPORT TROLLY WAS DAMAGED, AND THAT THE DEVICE WAS UNSTABLE. THE DEVICE WAS NOT IN CLINICAL USE WHEN THE ISSUE WAS OBSERVED. NO PATIENT IMPACT AND/OR HARM REPORTED. THE CUSTOMER CONFIRMED THE ISSUE; THE SERVICE ENGINEER (SE) THAT ASSISTED THE CUSTOMER, NOTED THAT THE COLUMN WAS LOOSE FROM THE BRACKET. IT WAS NOTED THAT THE ASSEMBLY STAND WOULD NEED TO BE REPLACED. THE INVESTIGATION IS ONGOING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25375786 ↗MalfunctionMay 20, 2026Inadequate User Interface
PHILIPS RECEIVED A COMPLAINT BY THE BIOMEDICAL TECHNICIAN ON THE V60 INDICATING A DEVICE MALFUNCTION; FOLLOWING THE HANDLING OF THE BED, THE DEVICE RECEIVED IMPACT TO THE SCREEN, AND TOUCHSCREEN WAS NO LONGER WORKING. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME THE REPORTED ISSUE WAS DISCOVERED; HOWEVER, THERE WAS NO REPORTED HARM TO THE PATIENT OR USER. THE BIOMEDICAL TECHNICIAN CALLED TECHNICAL SUPPORT TO REPORT THAT THE TOUCHSCREEN WAS NOT WORKING FOLLOWING THE HANDLING OF THE BED. THE REMOTE SERVICE ENGINEER (RSE) RECOMMENDED A TOUCHSCREEN REPLACEMENT TO REMEDY THE ISSUE AND PROVIDED THE CUSTOMER WITH THE PART NUMBER OF THE REPLACEMENT TOUCHSCREEN. GIVEN THAT THE BIOMEDICAL TECHNICIAN IS NOT TRAINED TO PERFORM THE REPAIR, THE BIOMEDICAL TECHNICIAN REQUESTED A SERVICE QUOTE FOR AN ONSITE INTERVENTION. THE INVESTIGATION IS ONGOING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25232186 ↗MalfunctionMay 19, 2026Failure to Charge
PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT THE BATTERY DOES NOT CHARGE. IT IS UNKNOWN IF THE UNIT WAS IN PATIENT USE AT THE TIME OF THE REPORTED ISSUE. NO PATIENT OR USER HARM WAS REPORTED. FINAL INVESTIGATION AND DISPOSITION ARE PENDING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25221716 ↗MalfunctionMay 11, 2026Inadequate User Interface
PHILIPS RECEIVED A COMPLAINT REGARDING A V60 VENTILATOR INDICATING A TOUCHSCREEN MALFUNCTION, WHERE THE TOUCHSCREEN WAS FOUND TO BE DEFECTIVE AND NOT FUNCTIONING AS EXPECTED. THE ISSUE RESULTED IN THE DEVICE NOT BEING USED BY THE CUSTOMER, AND ANOTHER DEVICE WAS UTILIZED INSTEAD. THE CURRENT SOFTWARE VERSION IS UNKNOWN. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. NO PATIENT IMPACT WAS REPORTED, AND NO USER HARM WAS IDENTIFIED. A FIELD SERVICE ENGINEER (FSE) EVALUATED THE DEVICE AND DETERMINED THAT THE TOUCHSCREEN IS FAULTY AND REQUIRES REPLACEMENT. THE INVESTIGATION IS ONGOING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25142721 ↗MalfunctionMay 8, 2026Inadequate User Interface
PHILIPS RECEIVED A COMPLAINT REGARDING A V60 VENTILATOR DESCRIBING A TOUCHSCREEN CALIBRATION AND ALIGNMENT ISSUE RESULTING IN INACCURATE AND INCONSISTENT TOUCHSCREEN RESPONSE DURING OPERATION. IT IS UNKNOWN IF THE UNIT WAS IN PATIENT USE AT THE TIME OF THE REPORTED ISSUE, AND NO PATIENT OR USER HARM WAS REPORTED. THE EXPECTED DEVICE BEHAVIOR IS A FULLY RESPONSIVE AND ACCURATELY CALIBRATED TOUCHSCREEN INTERFACE; HOWEVER, THE ACTUAL BEHAVIOR OBSERVED AND REPORTED INCLUDED PERSISTENT MISCALIBRATION, MISALIGNMENT, AND INTERMITTENT TOUCHSCREEN RESPONSIVENESS, WHICH IMPACTED THE USER¿S ABILITY TO RELIABLY OPERATE THE DEVICE. THE DEVICE WAS EVALUATED BY PHILIPS FIELD SERVICE ENGINEER (FSE) DURING ONSITE SERVICE ACTIVITIES. TROUBLESHOOTING INCLUDED REPEATED RECALIBRATION ATTEMPTS, FUNCTIONAL ASSESSMENT OF THE TOUCHSCREEN UNDER SERVICE AND CLINICAL MODES, AND DIAGNOSTIC EVALUATION OF SYSTEM PERFORMANCE. THESE ATTEMPTS DID NOT RESTORE NORMAL OPERATION, AND THE TOUCHSCREEN FAILURE WAS REPRODUCIBLE. BASED ON DIAGNOSTIC FINDINGS, THE TOUCHSCREEN ASSEMBLY WAS IDENTIFIED AS THE MOST LIKELY FAILED COMPONENT. THE PART WAS REPLACED, AND ELECTRICAL SAFETY TESTING WAS PERFORMED AS PART OF THE SERVICE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25126975 ↗MalfunctionMay 4, 2026Inadequate User Interface
PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THE TOUCHSCREEN WAS NOT WORKING. THE DEVICE WAS REPORTED TO BE IN USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT OR USER HARM REPORTED. THE CUSTOMER INFORMED THE REMOTE SERVICE ENGINEER (RSE) THAT THEY WERE REQUESTING ONSITE SUPPORT BY A FIELD SERVICE ENGINEER (FSE) TO EVALUATE AND SERVICE THE ISSUE. THIS INVESTIGATION IS ONGOING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25068798 ↗MalfunctionApr 30, 2026Display Difficult to Read
PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER, REPORTING THAT THE V60 VENTILATOR HAD A DARK DISPLAY. THERE WAS NO PATIENT INVOLVEMENT WHEN THE ISSUE OCCURRED. NO PATIENT OR USER HARM REPORTED. THE CUSTOMER REPORTED THAT THE SCREEN WAS SLIGHTLY DARK WHEN SET TO MAXIMUM BRIGHTNESS. THE CUSTOMER REPORTED THAT ALL OTHER TESTS PASSED. THE REMOTE SERVICE ENGINEER (RSE) PROVIDED THE CUSTOMER WITH OPTIONS FOR REPAIR. DURING TROUBLESHOOTING, THE RSE IDENTIFIED THAT SWAPPING THE LCD (LIQUID CRYSTAL DISPLAY) AND TRAY ASSEMBLY WITH KNOWN GOOD PARTS MADE THE SCREEN BRIGHTER. IT WAS CONFIRMED THAT THE DEVICE HAD A FIRST-GENERATION LCD, AND THE RSE SUGGESTED UPGRADING TO THE SECOND-GENERATION SCREEN. THE CUSTOMER WAS PROVIDED WITH A QUOTE TO REPLACE THE PARTS REQUIRED FOR THE UPGRADE; HOWEVER, THE QUOTE WAS CANCELLED, AND THE RECORD WAS CLOSED WITH NO FURTHER ACTIONS PERFORMED BY PHILIPS. NO FURTHER DETAILS COULD BE OBTAINED REGARDING THE EVENT, AND IT COULD NOT BE DETERMINED IF THE CUSTOMER'S ISSUE WAS RESOLVED OR IF THE DEVICE HAS BEEN REPAIRED. NO PARTS WERE RETURNED FOR FAILURE INVESTIGATION. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. THE COMPLAINT WILL BE P
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25050900 ↗MalfunctionApr 29, 2026Failure to Run on Battery
PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT A BATTERY FAILURE HAD OCCURRED. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. IT WAS DISCOVERED AT BENCH REPAIR THAT A BATTERY FAILURE HAD OCCURRED. THE BENCH SERVICE ENGINEER (BSE) DETERMINED A REPLACEMENT OF THE BATTERY WAS REQUIRED. THE INVESTIGATION IS ONGOING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25032376 ↗MalfunctionApr 28, 2026Inadequate User Interface
PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT A NAV-RING FAILURE HAD OCCURRED. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. IT WAS DISCOVERED AT BENCH REPAIR THAT A NAV-RING FAILURE HAD OCCURRED. THE BENCH SERVICE ENGINEER (BSE) DETERMINED A REPLACEMENT OF THE NAV-RING WAS REQUIRED. DEVICE EVALUATION AND REPAIR ARE PENDING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25019606 ↗MalfunctionApr 24, 2026Defective Alarm
PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT THE UNIT DID NOT ALARM. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE REPORTED ISSUE WAS DISCOVERED; HOWEVER, THERE WAS NO HARM TO THE PATIENT OR USER. IT WAS REPORTED THAT THE UNIT DID NOT ALARM. THE CUSTOMER REQUESTED A DETAIL FUNCTIONAL CHECK WITH THE EXTRACTION OF THE ERROR LOGS. ONSITE SERVICE IS PLANNED. THE INVESTIGATION IS ONGOING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24983508 ↗MalfunctionApr 24, 2026Failure to Sense
PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER, REPORTING THAT THE V60 VENTILATOR THE CIRCUIT ALARM DOES NOT RING, AND THE PATIENT DISCONNECT ALARM TAKES TOO LONG TO INITIATE. IT WAS UNKNOWN HOW THE ISSUE WAS FOUND. NO PATIENT OR USER HARM REPORTED. THIS INVESTIGATION IS ONGOING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24981369 ↗MalfunctionApr 24, 2026Grounding Malfunction
PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT AN ELECTRICAL SAFETY TEST FAILURE HAD OCCURRED. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. IT WAS DISCOVERED AT BENCH REPAIR THAT AN ELECTRICAL SAFETY TEST FAILURE HAD OCCURRED. THE BENCH SERVICE ENGINEER (BSE) DETERMINED A REPLACEMENT OF THE POWER CORD WAS REQUIRED. THIS INVESTIGATION IS ONGOING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24980744 ↗MalfunctionApr 21, 2026Inadequate User Interface
PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THERE WAS A TOUCHSCREEN ISSUE. THE DEVICE WAS REPORTED TO BE IN USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT OR USER HARM REPORTED. THE CUSTOMER INFORMED THE REMOTE SERVICE ENGINEER (RSE) THAT THE BIOMEDICAL ENGINEER (BME) COULD NOT DUPLICATE THE ISSUE, BUT RESPIRATORY STAFF NOTICED THE ISSUE. THE RSE PROVIDED THE CUSTOMER WITH THE PART INFORMATION FOR THE TOUCHSCREEN TO ORDER A REPLACEMENT. THIS INVESTIGATION IS ONGOING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24940187 ↗MalfunctionApr 20, 2026Grounding Malfunction
PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT THE POWER CORD HAS MORE RESISTANCE THAN ALLOWED IN ELECTRICAL TESTS. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. IT WAS DISCOVERED AT BENCH REPAIR THAT THE POWER CORD HAS MORE RESISTANCE THAN ALLOWED IN ELECTRICAL TESTS. THE BENCH SERVICE ENGINEER (BSE) DETERMINED A REPLACEMENT OF THE POWER CORD WAS REQUIRED. THIS INVESTIGATION IS ONGOING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24925617 ↗MalfunctionApr 17, 2026Intermittent Loss of Power
PHILIPS RECEIVED A COMPLAINT FROM THE SERVICE ENGINEER (SE), REPORTING THAT DURING DEVICE SERVICING, THE V60 VENTILATOR¿S SYSTEM BOARD NEEDED TO BE REPLACED AS IT WAS CAUSING THE DEVICE TO TURN ON AND OFF INTERMITTENTLY. THERE WAS NO PATIENT INVOLVEMENT WHEN THE ISSUE OCCURRED. THERE WAS NO PATIENT OR USER HARM REPORTED. A SERVICE QUOTE WAS PROVIDED TO THE CUSTOMER FOR APPROVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24916323 ↗MalfunctionApr 17, 2026Grounding Malfunction
PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT AN ELECTRICAL SAFETY TEST FAILURE OCCURRED. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. IT WAS DISCOVERED AT BENCH REPAIR THAT AN ELECTRICAL SAFETY TEST FAILURE OCCURRED. THE BENCH SERVICE ENGINEER (BSE) CONFIRMED THAT THE POWER CABLE AND POWER CORD BOTH HAD MORE RESISTANCE THAN ALLOWED IN THE ELECTRICAL TESTS. THE BSE DETERMINED A REPLACEMENT OF BOTH THE POWER CABLE AND CORD WAS REQUIRED. DEVICE EVALUATION AND REPAIR ARE PENDING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24914744 ↗MalfunctionApr 16, 2026Failure to Run on Battery
PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER ON THE V60 VENTILATOR INDICATING THAT A BATTERY FAILURE OCCURRED. THE BATTERY HAS MORE THAN 5 YEARS OF USE AS MARKED BY THE MANUFACTURER, AND IT CAUSES A TECHNICAL ALARM FOR "INTERNAL BATTERY FAILURE". IT IS UNKNOWN IF THE UNIT WAS IN PATIENT USE AT THE TIME OF THE REPORTED ISSUE. THERE WAS NO PATIENT OR USER HARM REPORTED. THE UNIT WAS SENT TO BENCH REPAIR. AT BENCH REPAIR, THE BENCH SERVICE ENGINEER (BSE) CONFIRMED THE ALARM FOR BATTERY FAILURE. THE BSE DETERMINED THAT A BATTERY REPLACEMENT WAS REQUIRED. PER THE USER AND SERVICE MANUAL FOR V60, THE BATTERY SHOULD BE REPLACED EVERY 5 YEARS. THE BATTERY REPLACEMENT IS BASED ON THE DATE OF MANUFACTURE RECORDED ON THE BATTERY LABEL. THE BATTERY AGE IS ALSO VIEWABLE IN THE DIAGNOSTIC MODE ON THE SYSTEM INFORMATION SCREEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24899549 ↗
Other Ventilator, continuous, minimal ventilatory support, facility use devices
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- BiPAP A40 EEX3100S19Respironics, Inc. · Ventilator, continuous, minimal ventilatory support, facility use2 recalls422 reports
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- BiPAP A40 ITX3100S21Respironics, Inc. · Ventilator, continuous, minimal ventilatory support, facility use2 recalls163 reports
- PHILIPS 1053613Respironics California, Inc. · Ventilator, continuous, minimal ventilatory support, facility use2 recalls1 death161 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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