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ECG100+

CARDIOLINE SPA · Model ECG100+ · UDI-DI 08056732653610

DPS Prescription

510(k) clearances

898

Adverse events (35 deaths)

Recalls

181

Facilities

Description

12 lead high performance multichannel interpretative resting electrocardiograph which displays, acquires, prints and stores ECG tracings for adults and children 4,3 display and 100mm printer paper

Recalls

Date	Firm	Reason
2026-07-20	Midmark Corporation	A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
2026-07-01	Philips North America Llc	Device will intermittently provide inaccurate data related to native heart rate.
2026-07-01	Philips North America Llc	Device will intermittently provide inaccurate data related to native heart rate.
2026-06-29	GE Medical Systems Information Technologies Inc	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
2025-09-12	Philips North America	Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.
2025-09-12	Philips North America	Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.
2025-08-22	GE Medical Systems, LLC	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
2025-03-24	Baxter Healthcare Corporation	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 batter
2024-12-18	Braemar Manufacturing, LLC	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 se
2024-10-11	Baxter Healthcare Corporation	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

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.