FDAFDA · Food and drugs·Recall number Z-2059-2014
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.
Published July 23, 2014 · Recall initiated: May 19, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mindray DS USA, Inc. dba Mindray North America
- Distributor
- Worldwide Distribution - US including the states of Louisiana, New Jersey, Montana, South Carolina and Wyoming.
- Lot
- Part Number (P/N): 0998-00-1800-101 and 0998-00-1800-201 with software version 2.4.1.18 in use with 12-lead ECG Module, P/N:0998-00-1804-01 and 0998-00-1804-02.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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