Q-Stress QS6-MLTC1Recalls & reported problems

Mortara Instrument, Inc. · Cardiac Stress Testing System · Class 2

All models of Q-Stress (17)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812345027631), received between Sep 17, 2025 and Sep 17, 2025 — classified as 1 malfunction.

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

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Patient Data Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

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 ↗

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-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).

Device details

UDI-DI	`00812345027631`
Brand	Q-Stress
Model	QS6-MLTC1
Company	Mortara Instrument, Inc.
Product code	DPS · Electrocardiograph
Class	Class 2
FDA submission	K001492, K082173, K152944
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jun 29, 2020

Device type (GMDN): Cardiac stress exercise monitoring system

An assembly of devices comprising a stress exercise monitoring system designed to record electrocardiograph (ECG) signals from electrodes placed on a patient's limbs and chest while the patient engages in varying degrees of exercise on a device or system of a predetermined kind, e.g., an ergometer. The system will typically analyse the recorded data, display results, monitor various functions, provide control of the workload, and give printouts, providing the clinician with a complete representation of the electrical activity of the heart, including heart rate.

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All Electrocardiograph devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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