Reported Oct 29, 2014 · Terminated
Mindray V21, Size: 515 mm X 335 mm X 685 mm, N.W.: 8 kg, G.W.: 11 kg, Qty:1 The V-Series Monitor is intended for intra…
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?
- Mindray V21
- Size
515 mm X 335 mm X 685 mmN.W.: 8 kgG.W.: 11 kg
- Qty1 The V-Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use include the monitoring of ECG waveform derived from 3,5,6 and 12-lead measurements, Heart Rate, Pulse Oximetry (Sp)s), ST Segment Analysis, Arrhythmia Detection, Non Invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Cardia Output (CO), Respiratory Gases, Respiration Rate and Temperature
- Lot codes and dates
- V-Series Monitoring System
- P/N
0998-00-1800-1010998-00-1800-201 and DA6KB-CTO-S01
- Amount recalled
- 2,247 units
Where it was sold
- Nationwide
Why it was recalled
Mindray DS USA Inc. initiated a voluntary field corrective action for V-Series Patient Monitor because there is an issue with the V-Series Drug Calculator function.
This product could cause temporary or reversible health problems — stop using it.
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