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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1096-2014

Invivo Corporation Expression IP5 Information Portal Product Usage: The Expression Information Portal (Model IP5) a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care professional to remotely monitor the vital signs of patients undergoing MRI procedures. Available monitoring from the IP5 can include ECG, SpO2, non-invasive and invasive blood pressure, CO2, respiration, anesthetic agents, gases, and temperature parameters.

Publicado el 5 de marzo de 2014 · Inicio del retiro: 3 de octubre 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

Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling their Expression Information Portal (Model IP5). Three different IP5 devices lost audio during use.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Invivo Corporation
Distribuidor
Worldwide Distribution - USA and the countries of Australia, Austria, Denmark, France, Germany, Netherlands, Poland, Singapore, Sweden, Switzerland, United Kingdom.
Lote
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Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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