RecallDepth

Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities.

Company
Mindray Ds Usa, Inc. D.B.A. Mindray North America
Recall Initiated
September 5, 2012
Posted
January 27, 2013
Terminated
October 22, 2013
Recall Number
Z-0742-2013
Quantity
13 units
Firm Location
Mahwah, NJ

Reason for Recall

Mindray has identified an issue with the DPM5 monitors where ST and Arrhythmia features may not be available.

Distribution

US Nationwide Distribution including the states of: VA, TN, FL, & TX

Lot / Code Info

p/n 9201F-PA000XX  DS-  0C000565 02000335 12000603 12000599 12000597 OCOOO569 9A000247 9A000252 17000648 06000490 05000470 05000466 02000373

Root Cause

Device Design

Action Taken

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.

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