Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The DigiTrak XT Record...
FDA Device Recall #Z-1345-2020 — Class II — January 13, 2020
Recall Summary
| Recall Number | Z-1345-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 13, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips North America, LLC |
| Location | Andover, MA |
| Product Type | Devices |
| Quantity | 44,442 units |
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.
Distribution Pattern
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
Lot / Code Information
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.
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Frequently Asked Questions
Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.