Mindray V12 Size: 320 mm X 320 mm X 450 mm N — Class II medical device recall Z-0528-2013
Terminated recall by Mindray DS USA, Inc. d.b.a. Mindray North America, reported 2012-12-26, distributed nationwide. Mindray has identified an issue with the V Series Monitor where the monitors touch screen may stop responding
| Recall number | Z-0528-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mindray DS USA, Inc. d.b.a. Mindray North America, Mahwah, NJ, United States |
| Recall initiated | 2012-09-24 |
| Classified | 2012-12-17 |
| Reported by FDA | 2012-12-26 |
| Terminated | 2013-08-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CO |
Product
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.
Reason for recall
Mindray has identified an issue with the V Series Monitor where the monitors touch screen may stop responding to touch.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.