FDAFDA · Alimentos y medicamentos·N.º oficial Z-0133-2014
The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power (0.585 watt average power per transducer) ultrasound to facilitate the delivery of physician-specified fluids in the peripheral vasculature and to deliver solutions into the pulmonary arteries. The EkoSonic Endovascular System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature and the infusion of solutions into the pulmonary arteries. The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, non sterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.
Publicado el 13 de noviembre de 2013 · Inicio del retiro: 2 de octubre de 2013
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
The EkoSonic Control Unit is recalled because it had the incorrect power entry module installed. It is missing an AC filter to reduce the noise and electrical interference.
Qué hacer
Voluntary: Firm initiated · E-Mail
Detalles del retiro
- Fabricante
- EKOS Corporation
- Distribuidor
- Worldwide Distribution in Germany only.
- Lote
- PT3B-783. PT3B represents the model number. Adding 783 creates the serial number.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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