FDAFDA · Alimentos y medicamentos·N.º oficial Z-2053-2020
Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or defibrillation. It must be used by or on the order of a physician.
Publicado el 27 de mayo de 2020 · Inicio del retiro: 13 de abril de 2020
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 rotary therapy selector switch may fail, resulting in unexpected device behavior including: 1) The device may not turn on; 2) The device may not perform the selected function;3) The device may deliver a shock with an energy level different than the setting selected by the user. In any of these scenarios, appropriate therapy delivery may be delayed.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Philips North America, LLC
- Distribuidor
- Worldwide distribution - US Nationwide distribution.
- Lote
- All units. Product has been discontinued.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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