FDA-Device2014-07-23Class II
V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. Used for monitoring of human physiological parameters. The V-Series Monitor also has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.
Mindray DS USA, Inc. dba Mindray North America
Hazard
ECG interpretation feature issues. False measurements reported when the algorithm cannot determine P wave or QRS axis. The Median Complex Report displays the representative beat 25% larger than actual signal input. When a patient date of birth is imported from an external source, the ECG interpretation algorithm uses the default age of 50, and interpretive statements may be incorrect.
Sold states
Worldwide Distribution - US including the states of Louisiana, New Jersey, Montana, South Carolina and Wyoming.
Affected count
113 units (57 United States; 56 International)
Manufactured in
800 MacArthur Blvd, N/A, Mahwah, NJ, United States
Products
V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. Used for monitoring of human physiological parameters. The V-Series Monitor also has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2059-2014Don't want to check this manually?
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