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U.S. Department of Health and Human Services

Class 2 Device Recall T1 Patient Monitor

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  Class 2 Device Recall T1 Patient Monitor see related information
Date Initiated by Firm April 28, 2017
Create Date June 27, 2017
Recall Status1 Terminated 3 on March 22, 2019
Recall Number Z-2634-2017
Recall Event ID 77390
510(K)Number K152902  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product TI Transport Monitor/Module Battery Pack

Product Usage:
intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters.
Code Information two sales brochures: p/n: 0002-08-30034 and 0002-08-30035  two copies of labels: 047-014270-00, 047-010964-00, 047-018754-00  two copies of operator's manuals: 115-040812-00 and TNC 14-FZ007-F-001
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 received two reports from outside the United States that the battery pack for TI transport monitor/module overheated.
FDA Determined
Cause 2		 Under Investigation by firm
Action Mindray notified their customers on April 28, 2017.Customers are provided information regarding this correction. Once the customer has identified the batteries, the customer should contact Mindray Customer Service to arrange for the no charge delivery of replacements. Mindray Customer Service representatives may be reached at (800) 288-2121 (Option 3), Monday through Friday 8:30 amd -5:30 pm, ET.
Quantity in Commerce 2718 batteries
Distribution US Nationwide Distribution
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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