Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Manufactured in China Mindray V21 Size: 515 mm X 335 mm X 685 mm N.W.: 8 kg G.W.: 11 kg Qty:1 Manufactured in China One product, V Series monitor, available in two sizes: The V12 has a 12 inch screen, the V21 has a 21 inch screen. The V Series Monitor is a Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices. It also monitors of the following human physiological parameters: 1) ECG waveform derived from 3, 5, 6 and 12 lead measurements, 2) Heart Rate, 3) Pulse Oximetry (Sp O2), 4) ST Segment Analysis, 5) Arrhythmia Detection, 6) Non Invasive Blood Pressure (NIBP), 7) Invasive Blood Pressure (IBP), 8) Cardiac Output (CO), 9) Respiratory Gasses, 10) Respiration Rate, 11) Temperature, It is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner.
- Recall Initiated
- September 24, 2012
- Posted
- December 17, 2012
- Terminated
- August 15, 2013
- Recall Number
- Z-0528-2013
- Quantity
- 206 units (180 units domestic, 26 units foreign)
- Firm Location
- Mahwah, NJ
Reason for Recall
Mindray has identified an issue with the V Series Monitor where the monitors touch screen may stop responding to touch.
Distribution
Worldwide Distribution - USA (nationwide) and internationally to Great Britian, Colombia, and Australia.
Lot / Code Info
V Series Monitor P/N's 0998-00-1800-101 and 0998-00-1800- 201.
Root Cause
Nonconforming Material/Component
Action Taken
Mindray issued an "Urgent: V Series Monitoring System Corrective Action" letter dated 9/24/2012 via certified mail with return receipt verification to all hospitals. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact their Mindray Service Representative at 1-800-288-2121 to arrange for relplacement of the affected product. For questions regarding this recall call 201-995-8407.