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U.S. Department of Health and Human Services

Class 2 Device Recall Mindray DPM 7 Monitor

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  Class 2 Device Recall Mindray DPM 7 Monitor see related information
Date Initiated by Firm July 27, 2015
Date Posted September 04, 2015
Recall Status1 Terminated 3 on May 02, 2017
Recall Number Z-2737-2015
Recall Event ID 71934
510(K)Number K092449  
Product Classification Monitor, physiological, patient (with arrhythmia detection or alarms) - Product Code MHX
Product Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms)

Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead selectable), arrhythmia detection, ST Segment analysis, and heart rate.
Code Information Lot #14A18, PN: 6800F-PA00001, Serial Numbers: DU- 46002583, DU-46002587, DU-46002588, DU-46002589, DU-46002592, DU-46002594, DU-46002595, DU-46002596, DU-46002599, DU-46002600, DU-46002601, DU-46002605 and DU-46002606
Recalling Firm/
Manufacturer		 Mindray DS USA, Inc. dba Mindray North America
800 Macarthur Blvd
Mahwah NJ 07430-2001
For Additional Information Contact Ms. Diane Arpino
201-995-8407
Manufacturer Reason
for Recall		 The DPM 7 Monitors may display a black screen.
FDA Determined
Cause 2		 Under Investigation by firm
Action Mindray sent an Urgent Medical Device Correction / DPM 7 Monitor letter, dated July 27, 2015, to their affected customers via certified mail and return receipt. The letter identified the problem as well as the affected product, adverse effects on patients, and corrective action. The firm will repair the potentially affected monitor at no cost to the customer. Customers are to contact their Mindray Service Representative at 1-800-288-2121 to arrange for the repair.
Quantity in Commerce 13 units
Distribution Distributed to the states of CT, IA, KY, MS, PA, UT and WA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MHX and Original Applicant = SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
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