Recall – Holter recorder displays error and fails to function

Company: Philips North America, LLC
Date of Enforcement Report: 3/3/2020
Class II

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

  • Recall Number: Z-1345-2020

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.

RECALLING FIRM/MANUFACTURER

Philips North America, LLC on 1/13/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

44,442 units

DISTRIBUTION

US Nationwide and International

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