Q-Stress QS6-ATTD1Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00812345027563), received between Oct 31, 2023 and Jul 8, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Patient Data Problem” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

5 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 16, 2026.

Recalls naming this device

1. Oct 11, 2024Class IIOpen, Classified

   There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.

   Z-0321-2025 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2026Patient Data Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25756920 ↗
• MalfunctionJun 8, 2026Patient Data Problem

  BAXTER RECEIVED A REPORT STATING THAT AN EXAM HAD INCORRECT PATIENT DATA IN Q-STRESS. THE EVENT OCCURRED AFTER PATIENT USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25437196 ↗
• MalfunctionAug 6, 2024Patient Data Problem; Patient Data Problem

  THE CUSTOMER REPORTED THAT STUDY PATIENT INFORMATION CHANGED AT THE BEGINNING OF THE STUDY. 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 19921347 ↗
• MalfunctionOct 31, 2023Patient Data Problem; Patient Data Problem

  THE CUSTOMER REPORTED THE QSTRESS 6 HAD A NUMBER OF ISSUES WITH TEST REPORTS, INCLUDING THE PATIENT NAME SWITCHED INSIDE THE EXAM WHEN USED IN OBSERVATION MODE, AND WAS UNABLE TO USE SECONDARY PATIENT ID WHEN USING MWL ORDER. THERE WAS NO INJURY REPORTED. THIS EVENT HAS BEEN CAPTURED UNDER HILLROM COMPLAINT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18038835 ↗

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-0325-2025 · Oct 11, 2024 · Open, Classified
  Hillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagnostic Computer
• 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-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-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).