Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities.
FDA Recall Z-0742-2013 · Posted 2013-01-27
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Recalling FirmMindray DS USA, Inc. d.b.a. Mindray North America
Recall StatusTerminated
Product CodeMWI
Date Initiated2012-09-05
Date Terminated2013-10-22
Product Quantity13 units
Reason for Recall
Mindray has identified an issue with the DPM5 monitors where ST and Arrhythmia features may not be available.
Firm 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.
Root Cause
Device Design
Distribution Pattern
US Nationwide Distribution including the states of: VA, TN, FL, & TX
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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