Recall Z-1345-2020
Philips North America, LLC · initiated January 13, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: 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.
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 taken
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.
Details
- Recall number
- Z-1345-2020
- Initiated
- January 13, 2020
- Terminated
- June 22, 2023
- Product code
- MWJ – Electrocardiograph, Ambulatory (Without Analysis)
- 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 Iceland India Indonesia Iran Iraq Ireland Israel Italy Japan Jordan Kenya Korea, Republic of Kosovo…
- Recalling firm
- Philips North America, LLC, Andover, MA