Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall 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.

U.S. FDA — Device Enforcement · United States · 2014-05-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2059-2014
Date of alert
2014-05-19
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Mindray DS USA, Inc. dba Mindray North America
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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