FDA recall Z-2634-2017

Product

TI Transport Monitor/Module Battery Pack Product Usage: intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters.

Reason for recall

Mindray has received two reports from outside the United States that the battery pack for TI transport monitor/module overheated.

Distribution

US Nationwide Distribution

Key facts

Status

Terminated

Initiation date

2017-04-28

Report date

2017-07-05

Termination date

2019-03-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2634-2017