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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0854-2019

PageWriter TC50, Product 860310, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients

Publicado el 27 de febrero de 2019 · Inicio del retiro: 9 de enero de 2019

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Philips North America, LLC
Distribuidor
Domestic distribution nationwide. Foreign distribution worldwide.
Lote
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Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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