Reported Dec 26, 2012 · Terminated
Mindray V12 Size
Mindray DS USA, Inc. d.b.a. 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. d.b.a. Mindray North America · 800 MacArthur Blvd. · Mahwah, NJ · 07430
Is this the product you have?
Mindray V12 Size
11 of 11 products
| # | Product as published |
|---|---|
| 1 | ECG waveform derived from 3, 5, 6 and 12 lead measurements |
| 2 | Heart Rate |
| 3 | Pulse Oximetry (Sp O2) |
| 4 | ST Segment Analysis |
| 5 | Arrhythmia Detection |
| 6 | Non Invasive Blood Pressure (NIBP) |
| 7 | Invasive Blood Pressure (IBP) |
| 8 | Cardiac Output (CO) |
| 9 | Respiratory Gasses |
| 10 | Respiration Rate |
| 11 | Temperature, It is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. |
- Lot codes and dates
- V Series Monitor P/N's 0998-00-1800-101 and 0998-00-1800- 201.
- Amount recalled
- 206 units (180 units domestic, 26 units foreign)
Where it was sold
- Nationwide
Why it was recalled
Mindray has identified an issue with the V Series Monitor where the monitors touch screen may stop responding to touch.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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