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FIAB SPA · Model F2017/4FL · UDI-DI 08054953341248

DRX Prescription

510(k) clearances

1,611

Adverse events (24 deaths)

Recalls

192

Facilities

Description

Disposable oval-shaped ECG electrodes with liquid gel, Silver/Silver Chloride(SSC) sensor, 52x32mm dimensions and with 4mm socket . These electrodes dimensions have features that make them absolutely reliable during signal recording in rest tests, with a direct application onto the skin. The SSC sensor permits a reliable and stable recording and off-centered configuration allows a better quality of ECG signal and reduces artifacts. They comply with ANSI/AAMI EC12:2000 permitting the signal recovery after defibrillator discharge. After opening, the pouch can be folded to ensure a better preservation of the electrodes that remain inside. The products are latex-free.

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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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.