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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 January 27, 2013
Recall Status1 Terminated on October 22, 2013
Recall Number Z-0742-2013
Recall Event ID 63800
Premarket Notification
510(K) Number
K053234 
Product Classification Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) - Product Code MWI
Product Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities.
Code Information p/n 9201F-PA000XX DS- 0C000565 02000335 12000603 12000599 12000597 OCOOO569 9A000247 9A000252 17000648 06000490 05000470 05000466 02000373
Recalling Firm/
Manufacturer
Mindray DS USA, Inc. d.b.a. Mindray North America
800 MacArthur Blvd.
Mahwah, New Jersey 07430
For Additional Information Contact Ms. Diane Arpino
201-995-8407
Manufacturer Reason
for Recall
Mindray has identified an issue with the DPM5 monitors where ST and Arrhythmia features may not be available.
FDA Determined
Cause 2
DESIGN: Device Design
Action Mindray DS USA Inc. sent an Urgent Product Corrective Action letter on September 5, 2012 via Fed Ex with delivery confirmation to all users. The letter identifies the affected product, problem and actions to be taken. Customers were instructed to contact their Mindray Service Representative at 1-800-288-2121 Monday through Friday 8:30-5:30 pm, to schedule a software upgrade.
Quantity in Commerce 13 units
Distribution US Nationwide Distribution including the states of: VA, TN, FL, & TX
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 = MWI and Original Applicant = SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
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