Electrocardiograph

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.

Recent recalls

• 2026-08-25Open, ClassifiedSoftware design

  Midmark IQecg Digital ECG, Model/Catalog Number: 4-000-0061, 4-000-0062 Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18.

  A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.

• 2026-08-14Open, ClassifiedSoftware design

  Cardiac Workstation 5000. Product Number: 860439.

  Device will intermittently provide inaccurate data related to native heart rate.

• 2026-08-14Open, ClassifiedSoftware design

  Cardiac Workstation 7000. Product Number: 860441.

  Device will intermittently provide inaccurate data related to native heart rate.

• 2026-08-04Open, ClassifiedSoftware design

  GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph

  Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of inactivity. As a result, data from a previous patient may remain on the screen and could be incorrectly associated with a subsequent patient.

• 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.