HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106 Product Usage: Samaritan 300/300P PAD is indicated for use on victims of sudden cardiac arrest who are exhibiting the following signs: Unconsciousness Not breathing Without circulation
Publicado el 7 de noviembre de 2012 · Inicio del retiro: 13 de septiembre 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
Certain Samaritan 300/300P PAD devices may experience one or both of the following conditions that could affect the ability to deliver therapy to a patient in an SCA event if needed: Issue 1 (On/Off Issue): the device may turn itself on and off without input from the user. When this occures, the normal sequence of audible instruction prompts that occurs when the device is turned on will be emit
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Heartsine Technologies, Limited
- Distribuidor
- Worldwide Distribution and US (nationwide) in the following states: AK, AL, AP, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, WA, and WI.
- Lote
- Serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United Kingdom
¿Vendes productos como este?
Recalert vigila todo tu catálogo contra retiros como este, automáticamente.