Philips 860343Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00884838030299), received between Aug 6, 2019 and May 24, 2021 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Patient Data Problem” (10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 24, 2021Inadequate User Interface; Inadequate User Interface

  CUSTOMER REPORTED THE EMERGENCY STOP BUTTON IS NOT WORKING. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11872475 ↗
• MalfunctionApr 2, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  THE CUSTOMER REPORTED THAT INTERMITTENTLY THE TREADMILL IS NOT STOPPING WHEN STOP IS HIT ON THE SOFTWARE. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO PATIENT OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11609389 ↗
• MalfunctionDec 7, 2020Patient Data Problem

  CUSTOMER REPORTED 2 DIFFERENT PATIENT ID'S ARE PRINTING ON THE FINAL REPORT. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10960359 ↗
• MalfunctionNov 24, 2020Patient Data Problem

  CUSTOMER REPORTED THAT THEY SETUP A PATIENT FOR A STRESS TEST AND AFTER ENTERING IN THE PATIENT INFORMATION IT CHANGES TO ANOTHER PATIENT. THEN WHEN THEY FINISH THE TEST AND GO TO PRINT THE STUDY , IT WILL SHOW A DIFFERENT NAME AS WELL. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10890093 ↗
• MalfunctionNov 19, 2020Self-Activation or Keying

  CUSTOMER REPORTED THE UNIT IS SWITCHING PATIENTS DURING REPORTS. THERE WAS NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10869048 ↗
• MalfunctionNov 11, 2020Patient Data Problem

  CUSTOMER REPORTED THE REPORT IS SHOWING INFORMATION ON A DIFFERENT PATIENT. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10826171 ↗
• MalfunctionNov 3, 2020Patient Data Problem

  THE CUSTOMER REPORTED THE REPORT IS SHOWING INFORMATION ON A DIFFERENT PATIENT. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10780196 ↗
• MalfunctionOct 14, 2020Patient Data Problem

  CUSTOMER REPORTED THE PATIENT INFORMATION SAVED TO THE WRONG PATIENT WHEN THEY SAVED IT AFTER AN EXAM. THERE WAS NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10679243 ↗
• MalfunctionSep 22, 2020Patient Data Problem

  THE CUSTOMER REPORTED THAT SOMETIMES THE UNIT MIXES UP PATIENT DATA WITH OTHER PATIENTS. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10566345 ↗
• MalfunctionSep 18, 2020Self-Activation or Keying; Patient Data Problem

  THE CUSTOMER REPORTED THAT WHEN SAVING A STUDY, THE SYSTEM PULLS UP THE DEMOGRAPHIC INFORMATION OF A COMPLETED PATIENT RANDOMLY. IT WAS STATED THAT THIS HAS BEEN AN ONGOING ISSUE, HOWEVER, DETAILS REGARDING PAST ISSUES WERE NOT PROVIDED. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10554635 ↗
• MalfunctionAug 14, 2020Failure to Auto Stop

  THE CUSTOMER REPORTED BEING UNABLE TO STOP THE TREADMILL, INDICATING NEITHER THE EMERGENCY STOP BUTTON(ESB) NOR THE LANYARD STOPPED THE TREADMILL. THE DEVICE WAS NOT IN USE ON A PATIENT. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Patient Involvement

  MAUDE report 10408059 ↗
• MalfunctionAug 14, 2020Patient Data Problem

  THE CUSTOMER REPORTED THAT THE WRONG NAME PRINTS ON THE REPORT. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10407946 ↗
• MalfunctionAug 13, 2020Application Program Problem

  CUSTOMER REPORTED THE TREADMILL WILL NOT RESPOND TO THE PRE-PROGRAM PARAMETERS AND WILL NOT STOP WITH THE PATIENT ON IT. THERE WAS NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10401563 ↗
• MalfunctionMar 27, 2020Patient Data Problem

  CUSTOMER REPORTED THAT WHEN IN REPORT VIEW AFTER CONFIRMING TO PRINT THE TEST STUDY, THE NAME ON THE STUDY CHANGED. THERE WAS NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9889766 ↗
• MalfunctionMar 13, 2020Patient Data Problem

  CUSTOMER REPORTED A PATIENT'S NAME IN AN EXAM WAS OVERRIDDEN WITH A DIFFERENT NAME. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9829100 ↗
• MalfunctionMar 13, 2020Data Problem

  CUSTOMER REPORTED A PATIENT'S NAME IN AN EXAM WAS OVERRIDDEN WITH A DIFFERENT NAME. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9828983 ↗
• MalfunctionOct 25, 2019Computer Operating System Problem

  CUSTOMER REPORTED THE APPLICATION FREEZES DURING EXAMS. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9238754 ↗
• MalfunctionAug 6, 2019Application Program Freezes or Fails to Launch

  THE CUSTOMER REPORTED THAT DURING A PATIENT EXAMINATION, THE APPLICATION FROZE. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8864430 ↗