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Recall Observatory FDA recall evidence

Device 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.

Z-0528-2013

September 24, 2012

Class II

Product summary

Firm
Mindray DS USA, Inc. d.b.a. Mindray North America
Event
Event 63652
Status
Terminated
Classification
Class II
Quantity
206 units (180 units domestic, 26 units foreign)
Official record key
device-enforcement:Z-0528-2013

Official wording

Reason: Mindray has identified an issue with the V Series Monitor where the monitors touch screen may stop responding to touch.

Code information: V Series Monitor P/N's 0998-00-1800-101 and 0998-00-1800- 201.

Distribution pattern: Worldwide Distribution - USA (nationwide) and internationally to Great Britian, Colombia, and Australia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Mindray has identified an issue with the V Series Monitor where the monitors touch screen may stop responding to touch.