FDAFDA · Food and drugs·Recall number Z-0107-2015
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.
Published October 29, 2014 · Recall initiated: July 31, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mindray DS USA, Inc. dba Mindray North America
- Distributor
- Worldwide Distribution: US (nationwide) and internationally to: Austalia, Canada, Columbia, Germany, India, Indonesia, Ireland, Israel, Kuwait, Malaysia, New Zealand, Pakistan, Russian Federation, Saudi Arabia, South Africa, Sri Lanka, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Venezula.
- Lot
- V-Series Monitoring System, P/N: 0998-00-1800-101, 0998-00-1800-201 and DA6KB-CTO-S01.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.