Device evidence

device-recall:cfres:123285

Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Product Usage: The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use for the V Series include the monitoring of the following human physiological parameters: 1) ECG waveform derived from 3, 5, 6 and 12 lead measurements 2) Heart Rate 3) Pulse Oximtery 4) ST Segment 5) Arrhythmia Detection 6) Non Invasive Blood Pressure (IBP) 7) Cardiac Output (CO) 8) Respiratory Gases 9) Respiration Rate 10) Temperature The V series monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.

Official recall number

Z-0389-2014

Evidence summary

Product code: MHX
Recall status: Terminated
Event initiated: October 07, 2013
Root cause: Environmental control
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0389-2014