Stress ST80i Stress Test SystemRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00884838094840), received between May 23, 2022 and Jul 22, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Fail-Safe Did Not Operate” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2025Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  THE CUSTOMER REPORTED THAT THEY HIT THE EMERGENCY STOP BUTTON; HOWEVER, THE TREADMILL KEPT GOING. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT. NO ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22569522 ↗
• MalfunctionOct 9, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT THE EMERGENCY STOP BUTTON WAS NOT WORKING ON TREADMILL. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT. NO ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20406151 ↗
• MalfunctionMar 18, 2024Failure to Auto Stop; Failure to Auto Stop

  THE CUSTOMER REPORTED THE EMERGENCY STOP IS NOT STOPPING. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18924653 ↗
• MalfunctionMar 16, 2023Failure to Auto Stop; Failure to Auto Stop

  PHILIPS RECEIVED A COMPLAINT ON THE OEM TRACKMASTER TMX428 TREADMILL 220V INDICATING THAT THE EMERGENCY STOP (E-STOP) BUTTON WAS NO LONGER WORKING. IT IS UNKNOWN IF THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT, NO ADVERSE EVENT OR PATIENT HARM WAS REPORTED. THE BIOMED ENGINEER AT THE CUSTOMER FACILITY EVALUATED THE DEVICE AND DETERMINED THAT THE E-STOP BUTTON REQUIRES REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16556083 ↗
• MalfunctionFeb 22, 2023Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  THE CUSTOMER REPORTED THAT THE TREADMILL EMERGENCY STOP BUTTON WAS NOT FUNCTIONING PROPERLY ON THE PHILIPS ST80I STRESS TEST SYSTEM. IT IS UNKNOWN IF THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE REPORTED ISSUE. NO DEATH OR PATIENT / USER INJURY OR HARM WAS REPORTED. A PHILIPS REMOTE SERVICE ENGINEER (RSE) SPOKE TO THE BIOMED AT THE CUSTOMER SITE. DURING THE TESTING IT WAS CONFIRMED THAT THE CAUSE FOR THE REPORTED ISSUE WAS A FAILED EMERGENCY STOP BUTTON. THE BIOMED ORDERED AND WAS PROVIDED WITH A REPLACEMENT EMERGENCY STOP ASSEMBLY TO REPAIR THE DEVICE AND TO RESOLVE THE ISSUE. THE DEVICE FAILED TO WORK AS INTENDED. THIS ISSUE WAS CAUSED BY A MALFUNCTION OF THE DEVICE AND WAS RESOLVED BY THE CUSTOMER REPLACING THE EMERGENCY STOP ASSEMBLY. IT HAS BEEN CONCLUDED THAT NO FURTHER ACTION IS REQUIRED. THE DEVICE REMAINS AT THE CUSTOMER SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16415707 ↗
• MalfunctionFeb 17, 2023Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT WHILE A STRESS STUDY WAS BEING PERFORMED, THE TREADMILL E-STOP BUTTON WAS UNRESPONSIVE. THE PATIENT HAD TO JUMP OFF THE TREADMILL TO SAFELY EXIT THE TREADMILL. THERE WAS NO REPORT OF A DEATH OR SERIOUS INJURY, NOR WAS THERE A REPORT OF ANY ADVERSE IMPACT TO ANY USER OR PATIENT. A PHILIPS AUTHORIZED THIRD PARTY FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER FACILITY TO EVALUATE THE DEVICE. THE FSE CONFIRMED THAT THEY WERE UNABLE TO REPLICATE THE E-STOP ISSUE. THE FSE STATES THAT A FACILITY TECHNICIAN REMOVED AND REINSTALLED THE E-STOP BUTTON WHICH RESULTED IN THE E-STOP BUTTON STOPPING THE TREADMILL WHEN ENGAGED, RESOLVING THE ISSUE. THE FSE WAS UNABLE TO CONFIRM THAT THE E-STOP BUTTON HAD FAILED, AS IT WAS WORKING AS SPECIFIED DURING HIS EVALUATION. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED WE WERE UNABLE TO REPLICATE THE REPORTED PROBLEM. THE REPORTED PROBLEM WAS NOT CONFIRMED. THE DEVICE WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS AND NO FAILURE WAS IDENTIFIED. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16395474 ↗
• InjuryJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT THEY¿VE GONE TO SWITCH IT ON THE DEVICE WITH A PATIENT IN SITU, AND THE BELT HAS THROWN THIS PERSON BACKWARDS AND TREADMILL GONE INTO REVERSE. THE PATIENT IS HARMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16194404 ↗
• MalfunctionJun 21, 2022Unintended System Motion; Insufficient Device Problem Information; Unintended System Motion; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT RED BUTTON IS NOT STOPPING/ PIM NOT COMMUNICATING WITH COMPUTER. IT UNKNOWN IF THE DEVICE WAS IN USE AT THE TIME OF THE EVENT, NO REPORTED PATENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14758728 ↗
• MalfunctionMay 23, 2022Unintended System Motion; Unintended System Motion

  THE CUSTOMER REPORTED THAT THE TREADMILL CONTINUED TO RUN AFTER THE COMPLETION OF THE TEST, AND THE STOP BUTTON WAS NOT AVAILABLE. IT WAS ALSO STATED THAT THE DEVICE FROZE FROM ALLOWING TO PUT PATIENT COMMENTS. THE CUSTOMER ADVISED THAT THE ISSUE HAPPENED THE PRIOR WEEK AND COULD NOT RECREATE THE ISSUE. IT IS UNKNOWN IF THE DEVICE WAS IN CLINICAL USE AT THE TIME THE REPORTED ISSUE WAS DISCOVERED. NO ADVERSE EVENT INVOLVING A PATIENT OR USER WAS REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14470994 ↗