NA
FIAB SPA · Model U7959 · UDI-DI 08054242444933
LDD
Prescription
1
510(k) clearances
16,579
Adverse events (943 deaths)
31
Recalls
38
Facilities
Description
Disposable multifunction electrodes for external defibrillation, transthoracic synchronized cardioversion, transcutaneous cardiac stimulation and ECG monitoring. Designed for direct connection to cables and defibrillators, they are characterized by a low impedance and a reduced stimulation threshold, with an excellent adaptability to the patient’s skin. The protective foam insulator and the safety plug eliminate every risk of electric micro-shock. Electrodes equipped with connector for defibrillators CU MEDICAL SYSTEM / CMOS DRAKE. Adult version.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-10-28 | Remote Diagnostic Technologies Ltd. | Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number. |
| 2024-08-09 | Physio-Control, Inc. | Due to customer complaints and out of box failures, the firm is conducting a voluntary recall as a result of product failures (cracks and over-molding separation of the sterilizabl |
| 2024-05-09 | Remote Diagnostic Technologies Ltd. | Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the same patient may cause electrical noise or interference, which may lead to distortions |
| 2023-05-08 | Remote Diagnostic Technologies Ltd. | Defibrillator/pacemaker module (DPM) may encounter a problem causing communication from the Mainboard to the DPM to fail, leading to no or ineffective pacing with displayed error m |
| 2022-01-28 | Remote Diagnostic Technologies Ltd. | Distribution of Defibrillators that are not approved or cleared for distribution US Market. |
| 2020-11-17 | Remote Diagnostic Technologies Ltd. | A software error was detected within software version 1.3.4 for the Tempus LS device. When exiting pacer back into manual mode the pacer pulse wave may put the ECG calibration out |
| 2014-11-06 | ConMed Corporation | Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result |
| 2014-11-06 | ConMed Corporation | Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result |
| 2013-04-26 | Cardio Medical Products | Covidien received customer reports of Arcing/Sparking on the defibrillation electrode leadwire which may affect Cardio Medical Products Inc. defibrillator electrodes Model Number O |
| 2011-03-09 | ConMed Corporation | The product lot was assembled with an R2 Connector, rather than a Zoll Connector. |
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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.