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 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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: V-Series Monitoring System, P/N: 0998-00-1800-101, 0998-00-1800-201 and DA6KB-CTO-S01.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Mindray DS USA, Inc. dba Mindray North America
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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 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.
Product Codes/Lot Numbers:
V-Series Monitoring System, P/N: 0998-00-1800-101, 0998-00-1800-201 and DA6KB-CTO-S01.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0107-2015
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