FDA-Device2017-07-05Class II
TI Transport Monitor/Module Battery Pack Product Usage: intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters.
Mindray DS USA, Inc. dba Mindray North America
Hazard
Mindray has received two reports from outside the United States that the battery pack for TI transport monitor/module overheated.
Sold states
US Nationwide Distribution
Affected count
2718 batteries
Manufactured in
800 Macarthur Blvd, N/A, Mahwah, NJ, United States
Products
TI Transport Monitor/Module Battery Pack Product Usage: intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2634-2017Don't want to check this manually?
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