Home / Recalls / Medical Devices
Mindray DS USA, Inc. dba Mindray North America recalls 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 intr
Recalled October 29, 2014 · FDA recall Z-0107-2015 · Mindray DS USA, Inc.
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. · FDA Class II
Units
2,247 units
Sold at
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.
Description
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.
Product
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.
Manufacturer(s)
Mindray DS USA, Inc. dba Mindray North America
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →