AfibAlert / hom ecg+
LOHMAN TECHNOLOGIES, LLC · Model V2.0 · UDI-DI 00860003939734
Description
The hom ecg+ / AfibAlert® is a cardiac event recorder capable of recording and storing approximately thirty 45-second events in solid-state non-volatile memory. The hom ecg+ / AfibAlert® allows patients who have been diagnosed with, or are susceptible to developing atrial fibrillation (AF) to take periodic readings with a computerized rhythm monitor. The system was developed for the patient that is at risk or has been previously diagnosed with AF, has a history of heart bypass, ablation, or other cardiac abnormality, or is on heart (anti-arrhythmic) medication. In these cases, detecting and determining AF early can potentially reduce the risk of heart attack and stroke. The device can record a single channel of ECG data in three ways: (I) via the two thumb electrodes, (2) by applying wrist electrodes or (3) applying two sticky electrodes as instructed by their health care practitioner. In each case, the patient initiates the recording. An individual recording will take ~45 seconds. Immediately following data acquisition, an internal AF algorithm is used to analyze the patient's rhythm. The built-in graphical LCD display indicates the presence or absence of AF. If ECG data is present (whether or not AF is indicated) the device uses an internal cellular module to transfer the ECG data to the cloud to be viewed and/or shared with their physician or health care practitioner using either company developed or third party developed internet based software program(s).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-21 | GE Medical Systems China Co., Ltd. | Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient. |
| 2015-09-03 | Spacelabs Healthcare Inc | When the battery is inserted into the CardioCall ECG Event Recorder, the device beeps twice and is followed by a continuous ringing sound that only stops when battery is removed. T |
| 2015-01-09 | Alivecor SFO | Alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon use of the application. |
| 2011-09-26 | Lifewatch Services Inc | LifeWatch received complaints of minor shocks and burns during use of the LifeStar ACT systems with shorts in the leads. |
| 2011-09-26 | Lifewatch Services Inc | LifeWatch received complaints of minor shocks and burns during use of the LifeStar ACT systems with shorts in the leads. |
| 2011-09-26 | Lifewatch Services Inc | LifeWatch received complaints of minor shocks and burns during use of the LifeStar ACT systems with shorts in the leads. |
| 2008-01-23 | Cybernet Systems Corp. | A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with the instructions fo |
| 2008-01-23 | Cybernet Systems Corp. | A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with the instructions fo |
| 2008-01-23 | Cybernet Systems Corp. | A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with the instructions fo |
| 2008-01-23 | Cybernet Systems Corp. | A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with the instructions fo |
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