FDAFDA · Alimentos y medicamentos·N.º oficial Z-2401-2012
Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In addition, the product may be used in synchronized mode to terminate certain atrial and ventricular tachycardias and other arrhythmias resistant to drug therapy. The X Series may be used for cardiac pacing in conscious or unconscious patients for up to a few hours duration as an alternative to endocardial stimulation. The X Series may be used for the monitoring a patients electrocardiogram (ECG).
Publicado el 26 de septiembre de 2012 · Inicio del retiro: 16 de agosto de 2012
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
Shipped with incorrect software
Qué hacer
Voluntary: Firm initiated · Telephone
Detalles del retiro
- Fabricante
- ZOLL Medical Corporation
- Distribuidor
- Worldwide Distribution - US Nationwide including the states of: LA, MA, ME, NC, ND, NE, OH and the country of Germany.
- Lote
- Serial Numbers: AR11J000164, AR12E000853, AR12E000856, AR12E000868, AR12E000920, AR12E000922, AR12E000923, AR12E000931, AR12E000944 AR12F001100, AR12F001298,
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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