NA
FIAB SPA · Model F9053P · UDI-DI 08033003261675
DRX
Prescription
10
510(k) clearances
1,587
Adverse events (23 deaths)
20
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). F9053P model is oval-shaped electrodes, 23x30mm dimensions, equipped with 35cm long wire and 4mm socket, pre-gelled and they can be easily connected to the ECG monitor, avoiding pressure on the skin. Pediatric model.
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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData 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.