Q-Stress QS6-MTTC1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00812345027655), received between Sep 20, 2023 and Jan 23, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K001492, K082173, K152944); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2024Patient Data Problem; Patient Data Problem

  THE CUSTOMER REPORTED THE INCORRECT PATIENT KEEPS APPEARING ON COMPLETED EXAMS. THERE WAS NO ADVERSE EVENT REPORTED. THIS INCIDENT HAS BEEN CAPTURED UNDER HILLROM COMPLAINT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18562761 ↗
• MalfunctionSep 20, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  THE CUSTOMER REPORTED THAT DURING THE USE OF THE QSTRESS DEVICE IN CONJUNCTION WITH A TREADMILL, AFTER THE DEVICE PROGRESSED THE TEST/TREADMILL FROM STAGE 1 TO STAGE 2, THE PATIENT REQUESTED THE CAREGIVER TO STOP THE TREADMILL. OF NOTE, THIS PATIENT WAS REPORTED TO HAVE A "PHOBIA" OF TREADMILLS DUE TO THE PATIENT FALLING FROM A TREADMILL AT A PREVIOUS UNDISCLOSED TIME. WHEN THE CAREGIVER ATTEMPTED TO STOP THE TEST/TREADMILL VIA THE QSTRESS STOP BUTTON, THERE WAS NO RESPONSE, THE PATIENT THEN FELL SUSTAINING A MINOR ABRASION ON HER LEFT HIP. UPON THE ARRIVAL OF A SECOND CAREGIVER, THE SECOND CAREGIVER PRESSED THE ESTOP BUTTON ON THE TREADMILL TO STOP THE TREADMILL. THE PATIENT WAS ASSESSED AT THE TIME OF THE EVENT AS WELL AS AT A LATER TIME BY THE PATIENT'S PERSONAL HEALTHCARE PROVIDER. NO MEDICAL INTERVENTION WAS REQUIRED AT EITHER ASSESSMENT. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).

  Patient problems: Abrasion

  MAUDE report 17783294 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K001492, K082173, K152944. One submission often covers many models, so check the product and lot details in each record.

• Z-0321-2025 · Oct 11, 2024 · Open, Classified
  Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test
• Z-0325-2025 · Oct 11, 2024 · Open, Classified
  Hillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagnostic Computer
• Z-0705-2024 · Dec 8, 2023 · Open, Classified
  Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes: a) QS6 AM12Q KIT AHA XML / QS6-BXXCS: b) QS6 AM12Q KIT BCRT IEC / QS-6CC-DGCXX: c) QS6
• Z-0706-2024 · Dec 8, 2023 · Open, Classified
  XScribe Cardiac Stress Testing System, version 6, with below product names and codes: a) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-BXXXX; b) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-DXXXX; c) XS6
• Z-1817-2020 · Mar 18, 2020 · Terminated
  Q-Stress/XScribe. Q-Stress or XScribe is a diagnostic device capable of real time ECG display, heart rate measurement, ST analysis and ventricular ectopic beat detection using wire
• Z-1757-2010 · Mar 30, 2009 · Terminated
  Treadmill models TM55, TM65, and CR60 (brand names include Quinton, Burdick, and Cardiac Science).