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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Philips North America, LLC
Lot Codes / Batch Numbers
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.
Products Sold
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.
Philips North America, LLC is recalling Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The DigiTrak XT Recorder due to 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 wi. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026