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FIAB SPA · Model F9053RM · UDI-DI 08033003262726

DRX Prescription

510(k) clearances

1,587

Adverse events (23 deaths)

Recalls

192

Facilities

Description

Disposable ECG monitoring electrodes have features that make them absolutely reliable during long monitoring ECG recording (not longer than 72 hours). F9053RM model is round-shaped electrodes, Ø 32mm, equipped with 35cm long wire and 4mm socket, pre-gelled and it can be easily connected to the ECG monitor, avoiding pressure on the skin. The external layer in waterproof medical grade PE foam protects the skin beneath the electrode from air and contaminating fluids. F9053RM is radiotranslucent, therefore it allows the user to perform radiographic procedures without removing the electrode.

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.