Recall Z-0528-2013— Mindray DS USA, Inc. d.b.a. Mindray North America

Name: FDA recall Z-0528-2013
Creator: U.S. Food and Drug Administration
Published: 2012-09-24

Class II · Terminated

Class II FDA medical device recall by Mindray DS USA, Inc. d.b.a. Mindray North America, initiated 2012-09-24, terminated 2013-08-15. It names one FDA 510(k) clearance: K102004. 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.. Reason: Mindray has identified an issue with the V Series Monitor where the monitors touch screen may stop responding to touch..

Recalling firm: Mindray DS USA, Inc. d.b.a. Mindray North America
Classification: Class II
Status: Terminated
Initiated: 2012-09-24
Terminated: 2013-08-15
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K102004 — ENDEAVOUR MONITORING SYSTEMMindray DS USA, Inc.·cleared 2010-09-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.