Recall Z-1345-2020 · MWJ Electrocardiograph, Ambulatory (Without Analysis)
Philips North America, LLC
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
| Date | Jan 13, 2020 |
| Status | Terminated |
| Reason | 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. |
| Root 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 informati |
| Quantity | 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 Ic |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071733 | DL900 SERIES HOLTER RECORDER Braemar, Inc., Jul 24, 2007 |