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U.S. Department of Health and Human Services

Class 2 Device Recall TD60 Transmitter Battery Charger

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  Class 2 Device Recall TD60 Transmitter Battery Charger see related information
Date Initiated by Firm July 14, 2017
Create Date February 08, 2018
Recall Status1 Terminated 3 on December 17, 2018
Recall Number Z-0554-2018
Recall Event ID 79005
510(K)Number K150632  
Product Classification System,network and communication,physiological monitors - Product Code MSX
Product TD60 Transmitter battery charger used with the BeneVision Central Station, Part number 115-030108-00
Code Information All battery chargers with part number 115-030108-00
Recalling Firm/
Manufacturer		 Mindray DS USA, Inc. dba Mindray North America
800 Macarthur Blvd
Mahwah NJ 07430-2001
For Additional Information Contact Diane Arpino
800-288-2121
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MSX and Original Applicant = SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
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