PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: July 23, 2014 Initiated: May 19, 2014 #Z-2059-2014

Product Description

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.

Reason for Recall

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.

Details

Units Affected
113 units (57 United States; 56 International)
Distribution
Worldwide Distribution - US including the states of Louisiana, New Jersey, Montana, South Carolina and Wyoming.
Location
Mahwah, NJ

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Mindray DS USA, Inc. dba Mindray North America. Units affected: 113 units (57 United States; 56 International).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 23, 2014. Severity: Moderate. Recall number: Z-2059-2014.

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