Philips Respironics V60 (REF U1053617)Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00884838025738), received between Feb 24, 2017 and Dec 11, 2024 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (4 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, 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2024Unexpected Shutdown; Unexpected Shutdown

  PHILIPS RECEIVED A COMPLAINT BY BENCH REPAIR ON THE V60 INDICATING THAT WHILE SERVICING THE DEVICE, IT WAS OBSERVED THAT MOTOR CONTROLLER PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) IS EXHIBITING INTERMITTENT FUNCTIONALITY, LIKELY DUE TO A SHORT CAUSED BY THE EXPOSED AND DAMAGED MAINBOARD COMPONENTS. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. RESOLUTION AND DISPOSITION ARE PENDING - INVESTIGATION ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20906044 ↗
• MalfunctionAug 21, 2024Gas/Air Leak; Gas/Air Leak

  PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THE DEVICE PRODUCED A LOW LEAK CO2 REBREATHING RISK ERROR CODE. THE DEVICE WAS REPORTED TO BE IN USE AT THE TIME OF THE REPORTED PROBLEM. THERE WAS NO PATIENT OR USER HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20022284 ↗
• MalfunctionAug 12, 2024Gas/Air Leak; Gas/Air Leak

  PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THERE WAS A LOW LEAK CO2 REBREATHING ALARM. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT OR USER HARM REPORTED. THE CUSTOMER ACCEPTED A PROPOSAL FOR ONSITE SERVICE BY A FIELD SERVICE ENGINEER (FSE) AND A REPLACEMENT FLOW SENSOR ASSEMBLY (FSA). THIS INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19960396 ↗
• MalfunctionMay 15, 2024Power Problem; Power Problem

  PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER ON THE V60 VENTILATOR INDICATING THAT THE DEVICE HAS A BOOT UP 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19320713 ↗
• MalfunctionMay 8, 2024Unstable; Unstable

  PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER INDICATING THAT THE V60 DEVICE'S CART WAS UNSTABLE. THE CASTER WAS UNABLE TO BE FULLY SCREWED BACK IN. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO REPORT OF PATIENT OR USER HARM. THE REMOTE SERVICE ENGINEER (RSE) PROVIDED THE CUSTOMER WITH THE PART NUMBER FOR A STAND TO ORDER AND REPLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19269646 ↗
• MalfunctionApr 25, 2024Failure to Run on Battery; Failure to Run on Battery

  PHILIPS RECEIVED A COMPLAINT FROM THE FIELD SERVICE ENGINEER (FSE) ON THE V60 VENTILATOR INDICATING THAT WHILE PERFORMING PREVENTATIVE MAINTENANCE, IT WAS OBSERVED THAT THE DEVICE WAS GETTING ERROR CODE 1124 BATTERY FAILED MESSAGE. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO REPORT OF PATIENT OR USER HARM. THE FSE REPLACED THE BATTERY TO RESOLVE THE REPORTED ISSUE. THE DEVICE PASSED THE REQUIRED PERFORMANCE VERIFICATION TESTS PER PHILIPS STANDARDS AND WAS RETURNED TO SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19182881 ↗
• MalfunctionFeb 1, 2024Failure to Power Up; Failure to Power Up

  PHILIPS RECEIVED A COMPLAINT FROM CUSTOMER BIOMED REPORTING THE V60 VENTILATOR WOULD NOT POWER ON. THE DEVICE WAS REPORTED TO BE IN CLINICAL USE. THERE WAS NO REPORT OF HARM OR OTHER PATIENT IMPACT. THE DEVICE DID NOT MEET SPECIFICATIONS FOR INTENDED USE AND WAS REMOVED FROM SERVICE. A PHILIPS REMOTE SERVICE ENGINEER (RSE) EVALUATED THE ISSUE WITH THE BIOMED ENGINEER (BME) AND CONFIRMED THE 24-VOLT DC (DIRECT CURRENT) POWER SUPPLY AS FUNCTIONAL. THE BME INSTALLED A NEW BATTERY AND THE ISSUE PERSISTED. THE BME REQUESTED REPLACEMENT OF THE POWER MANAGEMENT (PM) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18627954 ↗
• MalfunctionAug 1, 2023Gas/Air Leak; Gas/Air Leak

  PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER, REPORTING THAT THE V60 VENTILATOR HAD A CO2 REBREATHING RISK ERROR. THE DEVICE WAS IN CLINICAL USE WHEN THE ISSUE OCCURRED. NO PATIENT OR USER HARM WAS REPORTED. THE REMOTE SERVICE ENGINEER (RSE) NOTED THAT THE CUSTOMER HAS A V60 VENTILATOR THAT HAS A CO2 REBREATHING ISSUES. THE CUSTOMER VERIFIED THAT THERE WAS AN ERROR CODE 1201 AND 1203 IN THE HISTORY EVENT LOG. THE CUSTOMER ALSO STATED THAT THE AVERAGE AIR DISPLAY WAS READING 1.6 SLPM, EVEN THOUGH THE DEVICE WAS SET TO 0. THE RSE RECOMMENDED REPLACING THE FLOW SENSOR ASSEMBLY OR GAS DELIVERY SYSTEM. THE CUSTOMER WAS PROVIDED WITH THE PART IDS IN ORDER TO PURCHASE REPLACEMENT PARTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17434095 ↗
• MalfunctionMar 27, 2023Inadequate User Interface; Inadequate User Interface

  PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THE TOUCHSCREEN WAS INTERMITTENTLY REACTING. THE DEVICE WAS REPORTED TO BE OUTSIDE OF USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT HARM REPORTED. THE REMOTE SERVICE ENGINEER (RSE) SPOKE TO THE CUSTOMER WHO STATED THAT THE TOUCHSCREEN WAS INTERMITTENTLY REACTING. THE CUSTOMER REQUESTED AND WAS PROVIDED WITH PART PRICING AND INFORMATION FOR A REPLACEMENT TOUCHSCREEN. GOOD FAITH EFFORTS (GFES) ARE BEING COMPLETED TO CONFIRM THE PART ORDER, PART REPLACEMENT, AND RESOLUTION OF THE REPORTED ISSUE. THIS INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16620479 ↗
• MalfunctionJan 30, 2023Gas/Air Leak; Gas/Air Leak

  PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER, REPORTING THAT THE V60 VENTILATOR HAD A CO2 REBREATHING RISK ERROR. THE DEVICE WAS IN CLINICAL USE WHEN THE ISSUE OCCURRED. NO PATIENT OR USER HARM WAS REPORTED. THE REMOTE SERVICE ENGINEER (RSE) NOTED THAT THE CUSTOMER HAS A V60 VENTILATOR THAT HAS A CO2 REBREATHING ISSUES. THE CUSTOMER VERIFIED THAT THERE WAS AN ERROR CODE 1201 AND 1203 IN THE HISTORY EVENT LOG. THE CUSTOMER ALSO STATED THAT THE AVERAGE AIR DISPLAY WAS READING 1.6 SLPM, EVEN THOUGH THE DEVICE WAS SET TO 0. THE RSE RECOMMENDED REPLACING THE FLOW SENSOR ASSEMBLY OR GAS DELIVERY SYSTEM. THE CUSTOMER WAS PROVIDED WITH THE PART IDS IN ORDER TO PURCHASE REPLACEMENT PARTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16264372 ↗
• MalfunctionFeb 3, 2021Overheating of Device

  THE CUSTOMER CALLED INTO TECHNICAL SUPPORT (TS) REPORTING THAT THE DEVICE IS GETTING A BLOWER TEMP ERROR, BLOWER MOTOR OVERHEATED. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11273203 ↗
• MalfunctionJan 14, 2021Temperature Problem

  THE CUSTOMER REPORTED ERROR BLOWER TEMPERATURE HIGH. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11175098 ↗
• MalfunctionDec 12, 2020Self-Activation or Keying; Unexpected Shutdown

  IT WAS REPORTED TO PHILIPS THAT THE DEVICE SHUTDOWN AND RESTARTED WHILE IN USE AND THE UNIT WAS ALARMING LOW PRIORITY ALARM EVEN THOUGH THE SETTINGS WERE NOT CHANGED. THE DEVICE WAS IN USE AT THE TIME OF THE EVENT. THERE WAS NO REPORT OF PATIENT OR USER HARM. A PHILIPS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO PROVIDE ADDITIONAL ASSISTANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10995800 ↗
• MalfunctionSep 18, 2020Defective Component

  IT WAS REPORTED TO PHILIPS THAT THE DEVICE HAD A POWER SUPPLY FAILURE. THE DEVICE WAS NOT BEING USED ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO PATIENT OR USER HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10557214 ↗
• MalfunctionSep 2, 2020Mechanical Problem

  THE CUSTOMER REPORTED NAVIGATION (NAV) RING DOES NOT WORK. THE DEVICE DID NOT HAVE PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED, THEREFORE, THERE WAS NO PATIENT OR USER HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10485446 ↗
• MalfunctionMay 7, 2020Failure to Shut Off

  THE BIOMED REPORTED BEING UNABLE TO SHUT UNIT OFF THE UNIT, CALIBRATE THE TOUCHSCREEN, OR ACHIEVE TOUCHSCREEN FUNCTIONALITY. THE CUSTOMER CONTACTED PRODUCT SUPPORT AND REQUESTED FOR SERVICE ASSISTANCE. PRODUCT SUPPORT PROVIDED THE CUSTOMER PART ID FOR THE TOUCHSCREEN. THE CUSTOMER REPORTED THAT THE UNIT WAS NOT IN USE ON A PATIENT. THE CUSTOMER REPLACED THE TOUCHSCREEN TO ADDRESS THE REPORTED ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10036508 ↗
• MalfunctionMay 1, 2020Failure to Deliver

  THE CUSTOMER REPORTED THE UNIT STOPPED DELIVERING PATIENT BREATHS. THE DEVICE DID HAVE PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED, HOWEVER, THERE WAS NO PATIENT OR USER HARM REPORTED. THE FIELD SERVICE ENGINEER (FSE) COULD NOT DUPLICATE CUSTOMER'S COMPLAINT. PERFORMED DIAGNOSTIC REPORT (DRPT) DOWNLOAD. NO CONTINUOUS BUILT-IN TEST (CBIT), POWER ON SELF-TEST (POST) OR ERROR CODES WERE FOUND. FOUND THAT UNIT WOULD INTERMITTENTLY SWITCH BETWEEN RUNNING ON INTERNAL BATTERY AND ALTERNATING CURRENT (A/C)POWER RESTORED. THE FSE RECOMMENDED TO CUSTOMER THAT THE POWER MANAGEMENT PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) SHOULD BE REPLACED. CUSTOMER DECLINED MANUFACTURE SUPPORT AND WILL ORDER PART AND REPAIR IN HOUSE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10019171 ↗
• MalfunctionNov 25, 2019Device Alarm System

  THE CUSTOMER REPORTED THE UNIT ALARMED WITH A PRIMARY ALARM FAILURE. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED, THEREFORE, THERE WAS NO PATIENT OR USER HARM REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9372506 ↗
• MalfunctionSep 3, 2019Defective Device

  THE CUSTOMER REPORTED A FAILED NAV-RING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8955179 ↗
• MalfunctionJun 6, 2019Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THE VENTILATOR FAILED THE O2 FLOW TEST DURING PREVENTATIVE MAINTENANCE. THERE WAS NO PATIENT OR USER INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8676206 ↗
• MalfunctionJun 3, 2019Crack

  THE CUSTOMER REPORTED THAT THE V60 UNIT HAD A DEFECTIVE TOUCH SCREEN. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE MALFUNCTION, BUT THERE WAS NO PATIENT OR USER HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8663976 ↗
• MalfunctionApr 26, 2019Temperature Problem

  IT WAS REPORTED THAT UNIT DECLARED A HIGH BLOWER TEMPERATURE ALARM. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8554659 ↗
• MalfunctionAug 1, 2018Failure to Power Up

  THE CUSTOMER REPORTED UNIT WILL NOT TURN ON. THE DEVICE WAS NOT IN USE AT THE TIME OF THE REPORTED EVENT; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7740698 ↗
• MalfunctionApr 25, 2017Device Displays Incorrect Message

  THE CUSTOMER REPORTED THAT THE VENTILATOR ALARMED WITH BATTERY FAILED ERROR. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6518101 ↗
• MalfunctionFeb 24, 2017Device Inoperable

  THE CUSTOMER REPORTED THE DEVICE VENT INOP; BLOWER STALLED. NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6356419 ↗