Reported Mar 4, 2020 · Terminated
Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The DigiTrak XT Recorder is available in four…
Philips North America, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips North America, LLC · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
- 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 Number860322
- Lot codes and dates
- 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.
- Amount recalled
- 44,442 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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