Home › Qt Medical, Inc. › QT ECG
QT ECG
Qt Medical, Inc. · Model QTPOS121U · UDI-DI 04719872980452
DRX
Prescription
10
510(k) clearances
1,587
Adverse events (23 deaths)
20
Recalls
192
Facilities
Description
The electrode is disposable with a sensing element and is designed for ECG. It is applied to the surface of the body, single-use only, and disposable.
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.