FDA Medical Device Recalls (openFDA)
Mindray DS USA, Inc. dba Mindray North America: TD60 Transmitter battery charger used with the BeneVision Central Station, Part number 115-030108-00
- Recall number
- Z-0554-2018
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America
- Product
- TD60 Transmitter battery charger used with the BeneVision Central Station, Part number 115-030108-00
- Status
- Terminated
- Initiated
- 2017-07-14
- Posted
- not on file
- Terminated
- 2018-12-17
- Reason
- A damaged circuit board in the battery charger can cause the battery to overcharge and the battery case to swell and separate.
- Root cause
- Component design/selection
- Action
- Certified letters were sent to all affected customers on 07/14/2017, to offer a replacement of the battery charger.
- Quantity
- 203
- Distribution
- Distributed in 26 states: AL, CA, CO, FL, GA, IA, IN, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, PA, SD, TX, UT, WA, and WY; and Puerto Rico.
- Lot, serial or model codes
- All battery chargers with part number 115-030108-00
- 510(k) numbers
- ["K150632"]
- PMA numbers
- not on file
- Product code
- MSX
- 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