CLASS II Device recall · Reported 26 Dec 2012 · FDA Enforcement Report

Mindray V12 Size: N.W.: G.W.: Qty:1 recalled

Mindray DS USA, Inc. d.b.a. Mindray North America is recalling Mindray V12 Size: N.W.: G.W.: Qty:1, distributed nationwide in the US. The recall was initiated on 24 Sep 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesV Series Monitor P/N's 0998-00-1800-101 and 0998-00-1800- 201.

Quantity recalled206 units (180 units domestic, 26 units foreign)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0528-2013
FDA event ID: 63652
Recalling firm: Mindray DS USA, Inc. d.b.a. Mindray North America, Mahwah, NJ
Classification: Class II
Status: Terminated
Recall initiated: 24 Sep 2012
FDA classified: 17 Dec 2012
Reported: 26 Dec 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: CPAP & Ventilators

Timeline

24 Sep 2012	Recall initiated by company
17 Dec 2012	Classified by FDA	+84 days
26 Dec 2012	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide

Questions about this recall

Is Mindray V12 Size: N.W.: G.W.: Qty:1 recalled?

Yes. Mindray DS USA, Inc. d.b.a. Mindray North America recalled Mindray V12 Size: N.W.: G.W.: Qty:1 on 24 Sep 2012. The recall is Class II and its status is Terminated. Recall number Z-0528-2013.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Mindray DS USA, Inc. d.b.a. Mindray North America

All 9

Reported	Class	Recall	Company	Reason	Where
3 Apr 2013Device	CLASS II	BS-200 Chemistry Analyzer Designed for clinical laboratory use recalled	Mindray DS USA, Inc. d.b.a. Mindray North America	Labeling Errors	NC, TX
20 Feb 2013Device	CLASS II	Mindray DS USA, Inc., DPM Central Monitoring System recalled	Mindray DS USA, Inc. d.b.a. Mindray North America	Lead & Heavy Metals	Nationwide
6 Feb 2013Device	CLASS II	Mindray DPM5 Monitor, a vital signs monitor used on human recalled	Mindray DS USA, Inc. d.b.a. Mindray North America	Device Malfunction	Nationwide
9 Jan 2013Device	CLASS II	DPM Central Station Mindray DS USA recalled	Mindray DS USA, Inc. d.b.a. Mindray North America	Device Malfunction	Nationwide
19 Dec 2012Device	CLASS II	DPM 6/7 Patient Monitor recalled by Mindray DS USA, Inc. d.b.a.	Mindray DS USA, Inc. d.b.a. Mindray North America	Lead & Heavy Metals	Nationwide

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