Reported Dec 4, 2013 · Terminated
Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Product Usage
Mindray DS USA, Inc. dba Mindray North America
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mindray DS USA, Inc. dba Mindray North America · 800 MacArthur Blvd · Mahwah, NJ · 07430-2001
Is this the product you have?
Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Product Usage
10 of 10 products
| # | Product as published |
|---|---|
| 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. |
- Lot codes and dates
- V Series Montor p/n 0998-00-1801-01 and the associated V Dock , p/n 0998-UC-180-01
- Amount recalled
- 1839 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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