FDAFDA · Alimentos y medicamentos·N.º oficial Z-0905-2014
Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number: 10-1357 (Generator assembly), 40-404-1(as shipped, including accessories) The Aquamantys3 System combines radio frequency (RF) energy and saline to reduce blood loss during and after surgical procedures. This patented Transcollation technology has been shown to reduce transfusion rates and may also reduce the need for other blood management procedures.
Publicado el 12 de febrero de 2014 · Inicio del retiro: 12 de noviembre 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 internal protection circuitry on the electrosurgical output that prevents a patient from exposure to DC voltage when the device is activated is being compromised during normal use.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Medtronic Advanced Energy, LLC
- Distribuidor
- Nationwide Distribution including CA, MO, PA, NJ, NY, OH, VA, TX, NC, DE, KS, TN, LA, IL, MI, SC, WI, and FL.
- Lote
- lowest serial number is GN001141; the highest is GN001704 (non-consecutive)
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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