Mindray DS USA, Inc. d.b.a. Mindray North America: Medical Device Recall in 2012 - (Recall #: Z-0513-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: August 11, 2010

Date Posted: December 19, 2012

Recall Number: Z-0513-2013

Event ID: 63614

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.

Status: Terminated

Product Quantity: 124 units

Code Information:

K092449 DPM 6- p/n 6802F-PA00001 DPM 7 - p/n 6800F-PA00001

Distribution Pattern:

Nationwide Distribution-USA (nationwide) including the states of WA, IL, FL, MN, SC, NV, MI, TN, PA, LA, NE, TX, and IA.

Voluntary or Mandated:

Voluntary: Firm initiated