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FIAB SPA · Model F9057PRM · UDI-DI 08054953341064

DRX Prescription

510(k) clearances

1,611

Adverse events (24 deaths)

Recalls

192

Facilities

Description

F9057PRM model is a disposable round-shaped ECG monitoring electrodes have features that make them absolutely reliable during long monitoring ECG recording (not longer than 72 hours). F9057PRM is pre-gelled, Ø 32mm, equipped with 50cm long wire and DIN 42802-1 1.5mm socket. The external surface is made of non woven fabric. The fabric is made of plastic polyethylene fiber (and not natural fiber) that guarantees the transpiration of the skin, but at the same time the resistance to liquids with which they may come into contact during their use. Adult and Pediatric model. F9057PRM model 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.