Severity
Moderate
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
Reported: March 4, 2020 Initiated: January 13, 2020 #Z-1345-2020 44,442 units units
Philips North America, LLC issued this FDA Devices recall on March 4, 2020. Classified as Moderate severity (Class II). Approximately 44,442 units units are affected. The recall was issued because: if an AAA battery is inserted in the recorder and a user attempts to start it, or if the recorder is inserted in the d…. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
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 indicate 44,442 units units are affected.
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.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 6 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
44,442 units
Related Recalls
6
6 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.
Details
- Recalling Firm
- Philips North America, LLC
- Units Affected
- 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 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
- Location
- Andover, MA
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 |
| Units affected | 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.
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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Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.
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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).