CARDIO MONITOR CENTER VISION
SHL TELEMEDICINE INTERNATIONAL LTD. · Model S-CV8-00 · UDI-DI 07290008960427
Description
The Cardio Monitor Center Vision™ is a stand-alone medical device software operating on the physical or virtual personal computer in the organizational network and designed to work in combination with the medical device (remote personal ECG transmitter) to receive medical data (digital ECG data as an input) converting it to the interpretable ECG graph (software output). The Cardio Monitor Centre Vision displays 12 ECG leads ECG and Rhythm strip. The software received the data via proxy server and converts it to the graph of voltage versus time, displaying the heart's electrical forces, as viewed from 12 different electrical perspectives (points of view) - 12 leads, created by electrodes touching the skin.
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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