Z-1611-2014Class II

DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying...

Name: Z-1611-2014 DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying...
Creator: Mindray DS USA, Inc. dba Mindray North America
Published: 2014-03-05
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2014-03-05 / Terminated

FDA source

Mindray DS USA, Inc. dba Mindray North America began a recall of DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, storing, and alarming of multiple... on 2014-03-05. FDA classified it as Class II and gives the reason as "The MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1611-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-05
Posted: 2014-05-13
Terminated: 2015-04-27
Recalling firm: Datascope Corp.
Product: DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, storing, and alarming of multiple physiological parameters including ECG, arrhythmia detection, ST segment analysis, heart rate (HR), respiration rate (RESP), temperature, pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS), cardiac output (C.O.) and respiration mechanics (RM)
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: The MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing.
FDA root cause: No Marketing Application
Action: Mindray DS Usa Inc. contacted their sole customer via phone on March 5, 2014. The affected products will receive software upgrade.
Quantity in commerce: 4 units
Distribution: US Nationwide Distribution in the state of OH
Product codes and lots: monitor p/n 6802F-PA00001 module p/n 115-001704-00/M51A-30-80876

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1611-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1611-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-21	2014-05-12

Product code MHX

K092449Class IIBeneview T Series Patient Monitors, Models Beneview T8, T6 and T5Shenzhen Mindray Bio-Medical Electronics Co., Ltd. / cleared 2010-08-30

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)