Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall T1 Patient Monitor

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall T1 Patient Monitorsee related information
Date Initiated by FirmApril 28, 2017
Create DateJune 27, 2017
Recall Status1 Terminated 3 on March 22, 2019
Recall NumberZ-2634-2017
Recall Event ID 77390
510(K)NumberK152902 
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
ProductTI 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 ContactMs. 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
ActionMindray 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 Commerce2718 batteries
DistributionUS Nationwide Distribution
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MHX
-
-