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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0528-2013

Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Manufactured in China Mindray V21 Size: 515 mm X 335 mm X 685 mm N.W.: 8 kg G.W.: 11 kg Qty:1 Manufactured in China One product, V Series monitor, available in two sizes: The V12 has a 12 inch screen, the V21 has a 21 inch screen. The V Series Monitor is a Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices. It also monitors of the following human physiological parameters: 1) ECG waveform derived from 3, 5, 6 and 12 lead measurements, 2) Heart Rate, 3) Pulse Oximetry (Sp O2), 4) ST Segment Analysis, 5) Arrhythmia Detection, 6) Non Invasive Blood Pressure (NIBP), 7) Invasive Blood Pressure (IBP), 8) Cardiac Output (CO), 9) Respiratory Gasses, 10) Respiration Rate, 11) Temperature, It is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner.

Publicado el 26 de diciembre de 2012 · Inicio del retiro: 24 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

Mindray has identified an issue with the V Series Monitor where the monitors touch screen may stop responding to touch.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Mindray DS USA, Inc. d.b.a. Mindray North America
Distribuidor
Worldwide Distribution - USA (nationwide) and internationally to Great Britian, Colombia, and Australia.
Lote
V Series Monitor P/N's 0998-00-1800-101 and 0998-00-1800- 201.
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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