Multi Parameter Patient Monitor — Class II medical device recall Z-0389-2014
Terminated recall by Mindray DS USA, Inc. dba Mindray North America, reported 2013-12-04, distributed nationwide. Mindray has identified an issue with V Series Monitor where the V Dock power pins connecting the V Series Moni
| Recall number | Z-0389-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mindray DS USA, Inc. dba Mindray North America, Mahwah, NJ, United States |
| Recall initiated | 2013-10-07 |
| Classified | 2013-11-25 |
| Reported by FDA | 2013-12-04 |
| Terminated | 2015-04-27 |
| Distributed | Nationwide (US) |
| Quantity | 1,839 units |
Product
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.
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.