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Recall Observatory FDA recall evidence

Device product

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

Z-2634-2017

April 28, 2017

Class II

Product summary

Firm
Mindray DS USA, Inc. dba Mindray North America
Event
Event 77390
Status
Terminated
Classification
Class II
Quantity
2718 batteries
Official record key
device-enforcement:Z-2634-2017

Official wording

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

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

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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