FDA Recall
Terminated
TI Transport Monitor/Module Battery Pack Product Usage: intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters.
Recall: Z-2634-2017
·
Initiated April 28, 2017
Recall
- Recall Number
- Z-2634-2017
- Event Number
- 77390
- Firm
- Mindray DS USA, Inc. dba Mindray North America
- FEI Number
- 2221819
- Product Code
- MHX
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- April 28, 2017
- Terminated
- March 22, 2019
- Address
- 800 Macarthur Blvd, Mahwah, NJ, 07430-2001
Description
TI Transport Monitor/Module Battery Pack Product Usage: intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters.
Reason
Mindray has received two reports from outside the United States that the battery pack for TI transport monitor/module overheated.
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.
Distribution
US Nationwide Distribution
Quantity
2718 batteries