Z-0528-2013Class II

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...

Name: Z-0528-2013 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...
Creator: Mindray DS USA, Inc. d.b.a. Mindray North America
Published: 2012-09-24
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2012-09-24 / Terminated / root cause: manufacturing process

FDA source

Mindray DS USA, Inc. d.b.a. Mindray North America began a recall of 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... on 2012-09-24. FDA classified it as Class II and gives the reason as "Mindray has identified an issue with the V Series Monitor where the monitors touch screen may stop responding to touch". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0528-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-24
Posted: 2012-12-17
Terminated: 2013-08-15
Recalling firm: Datascope Corp.
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.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: Mindray has identified an issue with the V Series Monitor where the monitors touch screen may stop responding to touch.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 206 units (180 units domestic, 26 units foreign)
Distribution: Worldwide Distribution - USA (nationwide) and internationally to Great Britian, Colombia, and Australia.
Product codes and lots: V Series Monitor P/N's 0998-00-1800-101 and 0998-00-1800- 201.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0528-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0528-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-17

Product code MHX

K102004Class IIEndeavour Monitoring SystemMindray DS USA, Inc. / cleared 2010-09-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)