Z-2634-2017 Class II Terminated
FDA device recall Z-2634-2017 was initiated by Mindray DS USA, Inc. dba Mindray North America on April 28, 2017 and is designated Class II. Reason for recall: Mindray has received two reports from outside the United States that the battery pack for TI transport monitor/module overheated. The recall status is terminated (terminated March 22, 2019). Affected quantity: 2718 batteries.
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