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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 Recall
Mindray DS USA Inc.
see related information
Date Posted December 11, 2012
Recall Status1 Terminated on August 02, 2013
Recall Number Z-0513-2013
Recall Event ID 63614
Premarket Notification
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/
Manufacturer
Mindray DS USA, Inc. d.b.a. Mindray North America
800 MacArthur Blvd.
Mahwah, New Jersey 07430
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Ms. Diane Arpino
201-995-8407
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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MHX and Original Applicant = SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
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