RecallDepth

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).

Company
Mindray Ds Usa, Inc. D.B.A. Mindray North America
Recall Initiated
August 11, 2010
Posted
December 11, 2012
Terminated
August 2, 2013
Recall Number
Z-0513-2013
Quantity
124 units
Firm Location
Mahwah, NJ

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.

Distribution

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

Lot / Code Info

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

Root Cause

Device Design

Action Taken

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.

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