Mindray DS USA, Inc. dba Mindray North America: Medical Device Recall in 2013 - (Recall #: Z-0389-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Product Usage: The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use for the V Series include the monitoring of the following human physiological parameters: 1) ECG waveform derived from 3, 5, 6 and 12 lead measurements 2) Heart Rate 3) Pulse Oximtery 4) ST Segment 5) Arrhythmia Detection 6) Non Invasive Blood Pressure (IBP) 7) Cardiac Output (CO) 8) Respiratory Gases 9) Respiration Rate 10) Temperature The V series monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.

Product Classification:

Class II

Date Initiated: October 7, 2013

Date Posted: December 4, 2013

Recall Number: Z-0389-2014

Event ID: 66755

Reason for Recall:

Mindray has identified an issue with V Series Monitor where the V Dock power pins connecting the V Series Monitor to the V Dock may lose spring tension, potentially causing the screen to temporarily go blank, lose communication with the central station monitor (when one is in use) or shut down. No patient related events have been reported to Mindray concerning the issue.

Status: Terminated

Product Quantity: 1839 units

Code Information:

V Series Montor p/n 0998-00-1801-01 and the associated V Dock , p/n 0998-UC-180-01

Distribution Pattern:

Worldwide Distribution - USA Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated