Mindray DS USA, Inc. dba Mindray North America: Medical Device Recall in 2014 - (Recall #: Z-2059-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 19, 2014

Date Posted: July 23, 2014

Recall Number: Z-2059-2014

Event ID: 68582

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.

Status: Terminated

Product Quantity: 113 units (57 United States; 56 International)

Code Information:

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.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated