FDAJanuary 13, 2020device

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...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

philips north americaphilipsphilips north

UPCs

4535640671512445356406716148453564067171964535640671817

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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... — Recall Details · AllClear