Z-2634-2017 Class II Terminated

Recalled by Mindray DS USA, Inc. dba Mindray North America — Mahwah, NJ

Recall Details

Product Type
Devices
Report Date
July 5, 2017
Initiation Date
April 28, 2017
Termination Date
March 22, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2718 batteries

Product Description

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 Pattern

US Nationwide Distribution

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