FDA Devices recall · Reported March 4, 2020
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
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 …
Philips North America, LLC recalled Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The DigiTrak X… - a moderate-severity action.
Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The DigiTrak X… was recalled by Philips North America, LLC in March 4, 2020. Reason: if an AAA battery is inserted in the recorder and a user attempts to start it, or if the recorder is inserte…. Check the official notice for the remedy. Verify recall #Z-1345-2020 with the FDA Devices before acting.
The recall
Philips North America, LLC issued this moderate-severity FDA Devices recall-if an AAA battery is inserted in the recorder and a user attempts to start it, or if the recorder is inserte….
- Moderate
- severity level
- 44K units
- affected scope
- Class II
- classification
- March 4, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1345-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1345-2020 |
| Date reported | March 4, 2020 |
| Date initiated | January 13, 2020 |
| Recalling firm | Philips North America, LLC |
| Firm location | Andover, MA |
| Affected scope | 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… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1345-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026