Class 2 Device Recall TD60 Transmitter Battery Charger

• Date Initiated by Firm: July 14, 2017
• Create Date: February 08, 2018
• Recall Status: Terminated 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
• FEI Number: 2221819
• 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: 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