Electrocardiograph

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2025-10-22Open, ClassifiedDevice Design

  MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU4

  If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cable. This is visible as a damaged sheath or exposed wires. If a damaged Acquisition Trunk Cable is not recognized and removed from service, the cable can overheat with continued use.

• 2025-10-16Open, ClassifiedProcess control

  Cardiac Workstation 5000; Model Number: 860439;

  Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.

• 2025-10-16Open, ClassifiedProcess control

  Cardiac Workstation 7000; Model Number: 860441;

  Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.

• 2025-04-14Open, ClassifiedProcess design

  Welch Allyn CP150 Electrocardiograph:

  There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.

• 2024-12-23Open, ClassifiedUse error

  Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.

  Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and subsequently reviewed due to an analysis step being disabled with the monitoring service application software.

• 2024-11-07Open, ClassifiedSoftware design

  Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test

  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.

• 2024-11-07Open, ClassifiedSoftware design

  Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; Electrocardiograph

  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.

• 2024-11-07Open, ClassifiedSoftware design

  Hillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagnostic Computer

  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.

• 2024-08-27Open, ClassifiedSoftware design

  CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570

  Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT AT-180 electrocardiographs.

• 2024-07-10Open, ClassifiedEmployee error

  Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP150A-1ENB. The Electrocardiograph is one of the tools that clinicians use to evaluate, diagnose, and monitor patient cardiac function.

  During manufacturing, the step to install an Electromagnetic Interference (EMI) Absorber was omitted. The purpose of the EMI absorber is to prevent EMI leakage that might potentially affect other devices in the vicinity or the device itself may be vulnerable to EMI resulting in device malfunction or unavailability.