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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 FirmSeptember 05, 2012
Date PostedJanuary 27, 2013
Recall Status1 Terminated 3 on October 22, 2013
Recall NumberZ-0742-2013
Recall Event ID 63800
510(K)NumberK053234 
Product Classification Monitor,physiological,patient(without arrhythmia detection or alarms) - Product Code MWI
ProductMindray 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 NJ 07430
For Additional Information ContactMs. 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		Device Design
ActionMindray 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 Commerce13 units
DistributionUS Nationwide Distribution including the states of: VA, TN, FL, & TX
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MWI
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