Food, drugs, devices › Philips North America, LLC
Device recall: Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The DigiTrak XT Recorder is available in four d
FDA enforcement event 84879 is a device recall by Philips North America, LLC of Andover, MA, initiated 13 Jan 2020 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 22 Jun 2023. Initiation: voluntary: firm initiated. Philips North America, LLC has 129 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Philips North America, LLC, Andover, MA.
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."
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…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1345-2020 | 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 -… | 44,442 units | Class II | Terminated | 4 Mar 2020 |
Context
Other enforcement events for Philips North America, LLC
All 129 events for Philips North America, LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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 does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 22 Jun 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.