CardioSen'C
SHL TELEMEDICINE INTERNATIONAL LTD. · Model 4.2 · UDI-DI 07290008960250
Description
The CardioSen’C is a personal, hand-held device, enabling an individual to immediately transmit a 12-lead ECG from anywhere and anytime, to a physician's office, hospital or monitoring center. The ECG measurement can be transmitted in real time via two distinct channels. The CardioSen’C produces an ECG-modulated acoustical tone that can be coupled with and transmitted by a standard or a cellular telephone. The data can also be transmitted digitally through a cellular telephone network by use of the device’sintegrated cellular modem. Either one of these two transmissions permits the complete and reliable transfer of a 12-lead ECG immediately to a certified medical body capable of interpreting the results.
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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