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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84879

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
January 13, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips North America, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-1345-2020
Recall number
Z-1345-2020
Initiated
January 13, 2020
Classification
Class II
Status
Terminated
Quantity
44,442 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

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.

Code information

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.

Distribution pattern

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