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FDAFDA · Food and drugs·Recall number 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.

Published December 26, 2012 · Recall initiated: September 24, 2012

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Mindray DS USA, Inc. d.b.a. Mindray North America
Distributor
Worldwide Distribution - USA (nationwide) and internationally to Great Britian, Colombia, and Australia.
Lot
V Series Monitor P/N's 0998-00-1800-101 and 0998-00-1800- 201.
Risk classification
Class II
Area (FDA)
device
Country
United States

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