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U.S. Department of Health and Human Services

Class 2 Device Recall Mindray DS USA Inc.

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  Class 2 Device Recall Mindray DS USA Inc. see related information
Date Initiated by Firm August 11, 2010
Date Posted December 11, 2012
Recall Status1 Terminated 3 on August 02, 2013
Recall Number Z-0513-2013
Recall Event ID 63614
510(K)Number K092449  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
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).
Code Information K092449  DPM 6- p/n 6802F-PA00001  DPM 7 - p/n 6800F-PA00001
Recalling Firm/
Mindray DS USA, Inc. d.b.a. Mindray North America
800 MacArthur Blvd.
Mahwah NJ 07430
For Additional Information Contact Ms. Diane Arpino
Manufacturer 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.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MHX and Original Applicant = SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD