KARDIOSCREEN
IMEDRIX INC. · Model 1612A-CL · UDI-DI 00860003374917
Description
KardioScreen is a portable and mobile device intended to acquire a resting, diagnostic ECG using surface electrodes from adult patients and pediatric patients age 14-21 years. The device is intended to be used by doctors and/or trained healthcare professionals in a hospital, medical professional's facility, clinic, physician's office or any medical outreach center. The device can acquire, display, analyze and print either 6-lead or 12-lead electrocardiograms which can be exported for external use. The recorded ECG signals can help users to analyze and diagnose heart disease, but the device is not meant as a sole means of diagnosis. Senior Virtual Health Device Details KS-A00104,KS-A00110,KS-A00111,KS-A00112,KS-A00115,KS-A00117,KS-A00122,KS-A00131,KS-A00133,KS-A00136,KS-A00138,KS-A00139,KS-A00142,KS-A00145,KS-A00148,KS-A00149,KS-A00150 KS Converter Details KS-CN-A00104,KS-CN-A00110,KS-CN-A00111,KS-CN-A00112,KS-CN-A00115,KS-CN-A00117,KS-CN-A00122,KS-CN-A00131,KS-CN-A00133,KS-CN-A00136,KS-CN-A00138,KS-CN-A00139,KS-CN-A00142,KS-CN-A00145,KS-CS-A00148,KS-CN-A00149,KS-CN-A00150 Cable Details CMP220113-003 202201130002,CMP220113-003 202201130017,CMP220110-004 202201140008,CMP220110-004 202201140015,CMP220113-003 202201130026,CMP220113-003 202201130009,CMP220110-004 202201140023,CMP220113-003 202201130021,CMP220113-003 202201130022,CMP220113-003 202201130004,CMP220110-004 202201140018,CMP220113-003 202201130018,CMP220113-003 202201130010,CMP220110-004 202201140033,CMP220110-004 202201140027,CMP220113-003 202201130024,CMP220113-003 202201130001
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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