RecallRadar

FDA Device recall Z-2634-2017

TI Transport Monitor/Module Battery Pack Product Usage: intended for monitoring, displaying, reviewing, storing, alarming and transferring…

On 2017-07-05 the FDA classified a Class II recall of TI Transport Monitor/Module Battery Pack Product Usage: intended for monitoring, displaying, reviewing, storing, alarming and transferring… by Mindray Ds Usa, citing mindray has received two reports from outside the United States that the battery pack for TI transport monitor/module overheated.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2634-2017
ClassificationClass II
Statusterminated
Initiated2017-04-28
Published2017-07-05
Last updated2026-09-13 11:54 UTC
CompanyMindray Ds Usa
DistributionUS

Product

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

Reason

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

Identifiers

code_info
two sales brochures: p/n: 0002-08-30034 and 0002-08-30035 two copies of labels: 047-014270-00, 047-010964-00, 047-01…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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2634-2017%22

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