Class 2 Device Recall DigiTrak XT Holter Recorder

• Date Initiated by Firm: January 13, 2020
• Create Date: February 21, 2020
• Recall Status: Terminated on June 22, 2023
• Recall Number: Z-1345-2020
• Recall Event ID: 84879
• 510(K)Number: K071733
• Product Classification: Electrocardiograph, ambulatory (without analysis) - Product Code MWJ
• Product: Philips DigiTrak XT Holter Recorder Software version number; B.1 and C.2.; The DigiTrak XT Recorder is available in four different configurations. Service tag numbers for these configurations are as follows:; - 453564067151 24-Hour Configuration; - 453564067161 48-Hour Configuration; - 453564067171 96-Hour Configuration; - 453564067181 7-Day Configuration; ; Model Number: 860322
• Code Information: All Philips 860322 DigiTrak XT Holter Recorder, manufactured or distributed before December 31, 2019, are affected, regardless of serial number, ship date, and date of manufacture.
• Recalling Firm/ Manufacturer: Philips North America, LLC; 3000 Minuteman Rd; Andover MA 01810-1032
• For Additional Information Contact: SAME; 978-659-3000
• Manufacturer Reason for Recall: if an AAA battery is inserted in the recorder and a user attempts to start it, or if the recorder is inserted in the docking station, the recorder will display Error: 602 and fail to function for a new patient study.
• FDA Determined Cause: Device Design
• Action: Philips Issued Medical Device Correction letter dated January 13, 2020 to U.S. customers, via priority mail. Philips Market Organizations are responsible for distributing the letters outside of the U.S. Instructions to Customer Philips is asking customers to follow the Action to be Taken by Customer/User section of the CIL: Upon receipt of this notification, promptly locate and isolate affected devices. The steps in the Instructions on Clearing Error 602 below may be used to reset your devices. Customers can contact Philips should they choose not to reset the device on their own. For information or support contact: your local Philips representative or call us at 1 -800-722-9377.
• Quantity in Commerce: 44,442 units
• Distribution: US Nationwide Foreign: Afghanistan Albania Algeria Argentina Armenia Aruba Australia Austria Azerbaijan Bangladesh Belarus Belgium Bermuda Bulgaria Burkina Faso Canada China C¿te D'Ivoire Croatia Curacao Cyprus Czech Republic Egypt France Germany Ghana Gibraltar Greece Guatemala Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Israel Italy Japan Jordan Kenya Korea, Republic of Kosovo Kuwait Latvia Lebanon Libya Luxembourg Macao Macedonia Malaysia Maldives Mali Malta Mauritius Mexico Mongolia Myanmar Nepal Netherlands Netherlands Antilles New Zealand Nicaragua Nigeria Norway Oman Pakistan Palestine, State of Panama Peru Philippines Poland Portugal Puerto Rico Qatar Romania Russian Federation Rwanda Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sri Lanka Suriname Sweden Switzerland Taiwan Thailand Trinidad and Tobago Turkey Uganda United Arab Emirates United Kingdom Uzbekistan Venezuela Viet Nam
• 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 = MWJ and Original Applicant = BRAEMAR, INC.