Q-StressRecalls & reported problems across all models

We found 17 models of Q-Stress by Mortara Instrument, Inc. in the FDA's device registry (GUDID). Together they are named in 12 adverse event reports in the FDA's MAUDE database, received between Sep 20, 2023 and Sep 18, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Patient Data Problem” (11 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Q-Stress recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Oct 11, 2024Open, 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 · names 7 of these models · Recall details · FDA record ↗

2. Dec 8, 2023Open, Classified

   Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.

   Z-0705-2024 · Root cause: Software design · names 12 of these models · Recall details · FDA record ↗

Most reported Q-Stress problems

Q-Stress models

17 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Q-Stress QSERV-6AA-XXXXB

  Electrocardiograph
  2 recalls1 report
• Q-Stress QS6-AXTDS

  Electrocardiograph
  2 recalls0 reports
• Q-Stress QS-6BD-ACAAB

  Electrocardiograph
  2 recalls0 reports
• Q-Stress QS-6ED-AEAAB

  Electrocardiograph
  2 recalls0 reports
• Q-Stress QS-6IA-AEDAB

  Electrocardiograph
  2 recalls0 reports
• Q-Stress QS6-ATTD1

  Electrocardiograph
  1 recall4 reports
• Q-Stress QS6-ATTDX

  Electrocardiograph
  1 recall3 reports
• Q-Stress QR-6AC-XXXXX

  Electrocardiograph
  1 recall0 reports
• Q-Stress QS-6EB-BXDXA

  Electrocardiograph
  1 recall0 reports
• Q-Stress QSERV-6AA-XXXXA

  Electrocardiograph
  1 recall0 reports
• Q-Stress QS-6GD-XGDAA

  Electrocardiograph
  1 recall0 reports
• Q-Stress QS-6AA-DDCAA

  Electrocardiograph
  1 recall0 reports
• Q-Stress QS-6FC-AXDXA

  Electrocardiograph
  1 recall0 reports
• Q-Stress QS-6ID-AGDAA

  Electrocardiograph
  1 recall0 reports
• Q-Stress QS6-MTTC1

  Electrocardiograph
  2 reports
• Q-Stress QS6-MLTC1

  Electrocardiograph
  1 report
• Q-Stress QS6-MLTCX

  Electrocardiograph
  1 report

Recent Q-Stress adverse event reports

The 12 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Patient Data Problem

  Baxter received a report stating that an exam was done earlier under the wrong patient information. This occurred after patient use. There was no patient injury or death reported with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50812898 ↗
• MalfunctionSep 16, 2026Patient Data Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50796780 ↗
• MalfunctionAug 14, 2026Patient Data Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50261022 ↗
• 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 ↗
• MalfunctionJun 6, 2026Patient Data Problem

  BAXTER RECEIVED A REPORT STATING THAT AN EXAM WAS TAKEN UNDER THE WRONG PATIENT IN Q-STRESS. THE EVENT OCCURRED BEFORE 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 25418320 ↗
• MalfunctionSep 17, 2025Patient Data Problem; Patient Data Problem

  THE CUSTOMER CONTACTED BAXTER TO REPORT THE NURSE HAD SAVED AN EXAM WITH THE INCORRECT PATIENT INFORMATION. THERE WAS NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23070644 ↗
• MalfunctionAug 7, 2024Patient Data Problem; Patient Data Problem

  THE CUSTOMER REPORTED THAT WHEN RUNNING A PATIENT TEST THE SYSTEM WAS USING THE PREVIOUS PATIENT'S NAME. THERE WAS NO ADVERSE EVENT REPORTED. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REFERENCE #(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19929487 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

Other Mortara Instrument, Inc. products

• ELI 38011 models · 109 reports · 2 recalls
• XScribe Cardiopulmonary Kit3 models · 0 reports · 2 recalls
• HScribe8 models · 1 reports · 1 recall
• RScribe5 models · 0 reports · 1 recall
• XScribe2 models · 0 reports · 1 recall
• Vision Express4 models · 0 reports · 1 recall
• AM12M3 models · 0 reports · 1 recall
• Surveyor S192 models · 0 reports · 1 recall