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U.S. Department of Health and Human Services

Enforcement Report - Week of February 6, 2013

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Event Detail

Event ID 63800
Product Type Devices
Status Ongoing
Recalling Firm Mindray DS USA, Inc. d.b.a. Mindray North America
City Mahwah
State NJ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-05
Initial Firm Notification of
Consignee or Public
Distribution Pattern US Nationwide Distribution including the states of: VA, TN, FL, & TX

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Mindray, DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities. p/n 9201F-PA000XX DS- 0C000565 02000335 12000603 12000599 12000597 0C000569 9A000247 9A000252 17000648 06000490 05000470 05000466 02000373 Class II Mindray has identified an issue with the DPM5 monitors where ST and Arrhythmia features may not be available. 13 units Z-0742-2013