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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Mindray DS USA Inc.		see related information
Date Posted January 27, 2013
Recall Number Z-0742-2013
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
Reason for
Recall		 Mindray has identified an issue with the DPM5 monitors where ST and Arrhythmia features may not be available.
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
 
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