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Mindray DS USA, Inc. d.b.a. Mindray North America recalls 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 m
Recalled December 26, 2012 · FDA recall Z-0528-2013 · Mindray DS USA, Inc.
Hazard
Mindray has identified an issue with the V Series Monitor where the monitors touch screen may stop responding to touch. · FDA Class II
Units
206 units (180 units domestic, 26 units foreign)
Sold at
Worldwide Distribution - USA (nationwide) and internationally to Great Britian, Colombia, and Australia.
Description
Mindray has identified an issue with the V Series Monitor where the monitors touch screen may stop responding to touch.
Product
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.
Manufacturer(s)
Mindray DS USA, Inc. d.b.a. Mindray North America
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →