Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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.

FDA Recall Z-2059-2014 · Posted 2014-07-16

Recall StatusTerminated
Product CodeMHX
Date Initiated2014-05-19
Date Terminated2017-04-20
Product Quantity113 units (57 United States; 56 International)

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.

Firm Action

Mindray issued "Urgent: V-Series Monitoring System Corrective Action" notices dated May 19, 2014, to customers that received the affected product via certified mail with return receipt verification. The notification informs the customer of the issues with the affected product and how to identify the affected product. The notification recommends that customers discontinue use of the 12-lead ECG interpretation feature until a software correction is available (anticipate August 2014). A point of contact is provided to customers in case they have questions. For further questions please call 1-800-288-2121.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution - US including the states of Louisiana, New Jersey, Montana, South Carolina and Wyoming.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑