FDA Device recall Z-0389-2014
Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Product Usage: The V Series Monitor is intended for intra hospital u…
- FDA Device
- Class II
- terminated
- Published 2013-12-04
On 2013-12-04 the FDA classified a Class II recall of Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Product Usage: The V Series Monitor is intended for intra hospital u… by Mindray Ds Usa, citing 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 sc….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0389-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-07 |
| Published | 2013-12-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Mindray Ds Usa |
| Distribution | US |
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
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.
Identifiers
| code_info | V Series Montor p/n 0998-00-1801-01 and the associated V Dock , p/n 0998-UC-180-01 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0389-2014%22
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