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FIAB SPA · Model F9069NRM · UDI-DI 08054242444995

DRX Prescription

510(k) clearances

1,587

Adverse events (23 deaths)

Recalls

192

Facilities

Description

F9069NRM model is disposable ECG RADIOLUCENT electrode with solid gel, round-shaped Ø 26mm, Silver/Silver Chloride (SSC) sensor and carbon snap. The SSC sensor permits a reliable and stable recording. The peculiar feature of the electrode is the carbon snap that makes it radiolucent. Neither of the components contains any ferromagnetic materials, therefore the electrodes are fully compatible with MRI applications. The electrodes are MRI tested for use up to 3 T electro-magnetic field. The use of the electrodes do not affect the safety and functioning of Magnetic Resonance Imaging Systems. The external layer in waterproof medical grade PE foam protects the skin beneath the electrode from air and contaminating fluids

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.