Z-0513-2013Class II

DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430...

Name: Z-0513-2013 DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430...
Creator: Mindray DS USA, Inc. d.b.a. Mindray North America
Published: 2010-08-11
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2010-08-11 / Terminated / root cause: design

FDA source

Mindray DS USA, Inc. d.b.a. Mindray North America began a recall of DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Intended to be used for monitoring... on 2010-08-11. FDA classified it as Class II and gives the reason as "There is an issue with the DPM 6 and DPM 7 monitors where the following features may be unavailable : Full Disclosure, Drug, Hemodynamic Calculations, Renal Calculations, Oxygenation Calculations, and Ventilation...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0513-2013
Classification: Class II
Status: Terminated
Initiated: 2010-08-11
Posted: 2012-12-11
Terminated: 2013-08-02
Recalling firm: Datascope Corp.
Product: DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable). arrhythmia detection, ST Segment analysis, heart rate (HR) , respiration rate (RESP), temperature (TEMP), 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: There is an issue with the DPM 6 and DPM 7 monitors where the following features may be unavailable : Full Disclosure, Drug, Hemodynamic Calculations, Renal Calculations, Oxygenation Calculations, and Ventilation Calculations.
Root cause tag: design
FDA root cause: Device Design
Action: Mindray sent a "PRODUCT CORRECTIVE ACTION" letter dated August 11, 2010 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers should contact their Mindray Service Representative at 1-800-288-2121 for assistance with this issue.
Quantity in commerce: 124 units
Distribution: Nationwide Distribution-USA (nationwide) including the states of WA, IL, FL, MN, SC, NV, MI, TN, PA, LA, NE, TX, and IA.
Product codes and lots: K092449 DPM 6- p/n 6802F-PA00001 DPM 7 - p/n 6800F-PA00001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0513-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0513-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-19	2012-12-11

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