Home › CB Innovations, LLC › EXG Radiolucent Electrode System 4-Lead Electrode
EXG Radiolucent Electrode System 4-Lead Electrode
CB Innovations, LLC · Model EXGEES4L · UDI-DI 00860009331891
DRX
Prescription
10
510(k) clearances
1,721
Adverse events (24 deaths)
20
Recalls
191
Facilities
Description
The EXG Radiolucent Electrode with 4-Leads is indicated for use by healthcare professionals for ECG monitoring. This device is disposable, single use, and has been tested for up to 8-hour wear. It may be applied left arm to right arm, right chest to left abdomen, right chest to left chest, or right arm to left abdomen.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-03-15 | Graphic Controls Acquisition Corporation | Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard require |
| 2022-03-15 | Graphic Controls Acquisition Corporation | Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard require |
| 2022-03-15 | Graphic Controls Acquisition Corporation | Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard require |
| 2022-03-15 | Graphic Controls Acquisition Corporation | Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard require |
| 2022-03-15 | Graphic Controls Acquisition Corporation | Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard require |
| 2022-03-15 | Graphic Controls Acquisition Corporation | Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard require |
| 2021-10-06 | 3M Company - Health Care Business | Potential for breakage of the ECG electrode carbon stud from the eyelet. |
| 2020-09-15 | 3M Company - Health Care Business | Corrosion could cause performance failures in the product. |
| 2020-09-15 | 3M Company - Health Care Business | Corrosion could cause performance failures in the product. |
| 2020-09-15 | 3M Company - Health Care Business | Corrosion could cause performance failures in the product. |
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Get your free API keyRead the docsData 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.