Z-2059-2014Class II

V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. Used for monitoring of human...

Name: Z-2059-2014 V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. Used for monitoring of human...
Creator: Mindray DS USA, Inc. dba Mindray North America
Published: 2014-05-19
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2014-05-19 / Terminated / root cause: software

FDA source

Mindray DS USA, Inc. dba Mindray North America began a recall of V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. Used for monitoring of human physiological parameters. The V-Series Monitor also has... on 2014-05-19. FDA classified it as Class II and gives the reason as "ECG interpretation feature issues. False measurements reported when the algorithm cannot determine P wave or QRS axis. The Median Complex Report displays the representative beat 25% larger than actual signal input. When...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2059-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-19
Posted: 2014-07-16
Terminated: 2017-04-20
Recalling firm: Datascope Corp.
Product: V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. Used for monitoring of human physiological parameters. The V-Series Monitor also 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: ECG interpretation feature issues. False measurements reported when the algorithm cannot determine P wave or QRS axis. The Median Complex Report displays the representative beat 25% larger than actual signal input. When a patient date of birth is imported from an external source, the ECG interpretation algorithm uses the default age of 50, and interpretive statements may be incorrect.
Root cause tag: software
FDA root cause: Software design
Action: Mindray issued "Urgent: V-Series Monitoring System Corrective Action" notices dated May 19, 2014, to customers that received the affected product via certified mail with return receipt verification. The notification informs the customer of the issues with the affected product and how to identify the affected product. The notification recommends that customers discontinue use of the 12-lead ECG interpretation feature until a software correction is available (anticipate August 2014). A point of contact is provided to customers in case they have questions. For further questions please call 1-800-288-2121.
Quantity in commerce: 113 units (57 United States; 56 International)
Distribution: Worldwide Distribution - US including the states of Louisiana, New Jersey, Montana, South Carolina and Wyoming.
Product codes and lots: Part Number (P/N): 0998-00-1800-101 and 0998-00-1800-201 with software version 2.4.1.18 in use with 12-lead ECG Module, P/N:0998-00-1804-01 and 0998-00-1804-02.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2059-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2059-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-23	2014-07-16

Product code MHX

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)