FDA Medical Device Recalls (openFDA)
Mindray DS USA, Inc. dba Mindray North America: TI Transport Monitor/Module Battery Pack Product Usage: intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters.
- Recall number
- Z-2634-2017
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America
- Product
- TI Transport Monitor/Module Battery Pack Product Usage: intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters.
- Status
- Terminated
- Initiated
- 2017-04-28
- Posted
- not on file
- Terminated
- 2019-03-22
- Reason
- Mindray has received two reports from outside the United States that the battery pack for TI transport monitor/module overheated.
- Root cause
- Under Investigation by firm
- Action
- Mindray notified their customers on April 28, 2017.Customers are provided information regarding this correction. Once the customer has identified the batteries, the customer should contact Mindray Customer Service to arrange for the no charge delivery of replacements. Mindray Customer Service representatives may be reached at (800) 288-2121 (Option 3), Monday through Friday 8:30 amd -5:30 pm, ET.
- Quantity
- 2718 batteries
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K152902"]
- PMA numbers
- not on file
- Product code
- MHX
- Firm FEI
- 2221819
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28