Z-0554-2018 Class II Terminated
FDA device recall Z-0554-2018 was initiated by Mindray DS USA, Inc. dba Mindray North America on July 14, 2017 and is designated Class II. Reason for recall: A damaged circuit board in the battery charger can cause the battery to overcharge and the battery case to swell and separate. The recall status is terminated (terminated December 17, 2018). Affected quantity: 203.
Recall Details
- Product Type
- Devices
- Report Date
- February 14, 2018
- Initiation Date
- July 14, 2017
- Termination Date
- December 17, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 203
Product Description
TD60 Transmitter battery charger used with the BeneVision Central Station, Part number 115-030108-00
Reason for Recall
A damaged circuit board in the battery charger can cause the battery to overcharge and the battery case to swell and separate.
Distribution Pattern
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.
Code Information
All battery chargers with part number 115-030108-00