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Ambu WhiteSensor 0715M BIOTABSECG Electrodes

Ambu A/S · Model 0715M · UDI-DI 05060038513632

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

Description

Ambu White Sensor 0715M Electrod with solid gel and polymer backing and tab connector. Radiolucent and MR Conditional. Packaging: 100 pouch/ 500 inner box/ 5000 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.