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Ambu WhiteSensor 4500MECG Electrodes

Ambu A/S · Model 4500M · UDI-DI 05060038512482

DRX Prescription
10
510(k) clearances
1,587
Adverse events (23 deaths)
20
Recalls
192
Facilities

Description

Ambu White Sensor 4500M Electrode with wet gel and foam backing Center snap and PVC free. For short-term monitoring Packing: 30 pouch/300 inner box/ 3000 carton

Recalls

DateFirmReason
2022-03-15Graphic Controls Acquisition CorporationInstructions 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
2022-03-15Graphic Controls Acquisition CorporationInstructions 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
2022-03-15Graphic Controls Acquisition CorporationInstructions 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
2022-03-15Graphic Controls Acquisition CorporationInstructions 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
2022-03-15Graphic Controls Acquisition CorporationInstructions 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
2022-03-15Graphic Controls Acquisition CorporationInstructions 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
2021-10-063M Company - Health Care BusinessPotential for breakage of the ECG electrode carbon stud from the eyelet.
2020-09-153M Company - Health Care BusinessCorrosion could cause performance failures in the product.
2020-09-153M Company - Health Care BusinessCorrosion could cause performance failures in the product.
2020-09-153M Company - Health Care BusinessCorrosion could cause performance failures in the product.

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Data 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.