||January 27, 2013
||Terminated on October 22, 2013
|Recall Event ID
Monitor,physiological,patient(without arrhythmia detection or alarms) -
||Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities.
Mindray DS USA, Inc. d.b.a. Mindray North America
800 MacArthur Blvd.
|For Additional Information Contact
||Ms. Diane Arpino
|Mindray has identified an issue with the DPM5 monitors where ST and Arrhythmia features may not be available.
||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
||US Nationwide Distribution including the states of: VA, TN, FL, & TX
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K)s with Product Code = MWI and Original Applicant = SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD