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.
This recall has been terminated (originally issued October 21, 2014).
- Recall Initiated
- July 31, 2014
- Posted
- October 21, 2014
- Terminated
- April 20, 2017
- Recall Number
- Z-0107-2015
- Quantity
- 2,247 units
- Firm Location
- Mahwah, NJ
- Official Source
- View on FDA website ↗
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.
Distribution
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 / Code Info
V-Series Monitoring System, P/N: 0998-00-1800-101, 0998-00-1800-201 and DA6KB-CTO-S01.
Root Cause
Software design
Action Taken
Mindray DS USA, Inc. sent a Recall Correction Action Letter to their customers via certified mail with return receipt on July 31, 2014.