Severity
Moderate
ModerateClass IITerminated
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 …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
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 FDA Devices action (record #Z-1345-2020) was formally reported on March 4, 2020, with the manufacturer initiating the action on January 13, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Philips North America, LLC is listed as the recalling firm, operating out of Andover, MA. Federal records list the affected scope as 44,442 units.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: 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 Cu…. Distribution scope 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
44,442 units
Related Recalls
6
3 from same agency
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.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Philips North America, LLC. Units affected: 44,442 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 4, 2020. Severity: Moderate. Recall number: Z-1345-2020.
Where was the recalled product distributed? ▼
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 Kuwait Latvia Lebanon Libya Luxembourg Macao Macedonia Malaysia Maldives Mali Malta Mauritius Mexico Mongolia Myanmar Nepal Netherlands Netherlands Antilles New Zealand Nicaragua Nigeria Norway Oman Pakistan Palestine, State of Panama Peru Philippines Poland Portugal Puerto Rico Qatar Romania Russian Federation Rwanda Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sri Lanka Suriname Sweden Switzerland Taiwan Thailand Trinidad and Tobago Turkey Uganda United Arab Emirates United Kingdom Uzbekistan Venezuela Viet Nam.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1345-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 4, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.