Mindray DS USA, Inc. d.b.a. Mindray North America: Medical Device Recall in 2012 - (Recall #: Z-0528-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: September 24, 2012

Date Posted: December 26, 2012

Recall Number: Z-0528-2013

Event ID: 63652

Reason for Recall:

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

Status: Terminated

Product Quantity: 206 units (180 units domestic, 26 units foreign)

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.

Voluntary or Mandated:

Voluntary: Firm initiated