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U.S. Department of Health and Human Services

Class 2 Device Recall Mindray DS USA inc.

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  Class 2 Device Recall Mindray DS USA inc. see related information
Date Initiated by Firm June 23, 2016
Create Date August 16, 2016
Recall Status1 Terminated 3 on March 28, 2017
Recall Number Z-2549-2016
Recall Event ID 74704
510(K)Number K143195  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product Mindray DS USA Inc., Passport Series Patient Monitor intended for monitoring, displaying, reviewing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, arrythmia detection, ST segment analysis, and heart rate (HR), Respiration rate.
Code Information 100-00080-00 - Dyrline II Water Trap, Adult 115-020919-00- CO2 Module with Accessory Kit, Adult and Pediatric  Lot #1534, 1537, 1538, 1541, 1545, 1547, 1548, 1602, and 1606  
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
800-288-2121
Manufacturer Reason
for Recall		 Mindray has identified a potential leakage issue with the CO2 Module's Dryline II Water Trap used with the Passport Series Patient Monitor.
FDA Determined
Cause 2		 Under Investigation by firm
Action Mindray DS USA inc sent a recall letter on 6/23/2016 to their customers.
Quantity in Commerce 360 units
Distribution Nationwide, Canada
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-Meidcal Electronics Co., Ltd
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