Z-0389-2014Class II

Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms)

Name: Z-0389-2014 Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms)
Creator: Mindray DS USA, Inc. dba Mindray North America
Published: 2013-10-07
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2013-10-07 / Terminated / root cause: manufacturing process

FDA source

Mindray DS USA, Inc. dba Mindray North America began a recall of Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Product Usage: The V Series Monitor is intended for intra hospital use under the direct... on 2013-10-07. FDA classified it as Class II and gives the reason as "Mindray has identified an issue with V Series Monitor where the V Dock power pins connecting the V Series Monitor to the V Dock may lose spring tension, potentially causing the screen to temporarily go blank, lose...". 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-0389-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-07
Posted: 2013-11-25
Terminated: 2015-04-27
Recalling firm: Datascope Corp.
Product: Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Product Usage: The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use for the V Series include the monitoring of the following human physiological parameters: 1) ECG waveform derived from 3, 5, 6 and 12 lead measurements 2) Heart Rate 3) Pulse Oximtery 4) ST Segment 5) Arrhythmia Detection 6) Non Invasive Blood Pressure (IBP) 7) Cardiac Output (CO) 8) Respiratory Gases 9) Respiration Rate 10) Temperature The V series monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: Mindray has identified an issue with V Series Monitor where the V Dock power pins connecting the V Series Monitor to the V Dock may lose spring tension, potentially causing the screen to temporarily go blank, lose communication with the central station monitor (when one is in use) or shut down. No patient related events have been reported to Mindray concerning the issue.
Root cause tag: manufacturing process
FDA root cause: Environmental control
Action: Mindray sent an Urgent Corrective Action letter dated October 7, 2013 to all of their customers. The letter identified the affected product, problem and actions to be taken. Customers should contact their Mindray Service Representative at 1-800-288-2121 Monday through Friday from 830 am to 530 pm to arrange for the replacement of the affected product.
Quantity in commerce: 1839 units
Distribution: Worldwide Distribution - USA Nationwide
Product codes and lots: V Series Montor p/n 0998-00-1801-01 and the associated V Dock , p/n 0998-UC-180-01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0389-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0389-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-25

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)