Z-1345-2020Class II

Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The DigiTrak XT Recorder is...

Name: Z-1345-2020 Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The DigiTrak XT Recorder is...
Creator: Philips North America, LLC
Published: 2020-01-13
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2020-01-13 / Terminated / root cause: design

FDA source

Philips North America, LLC began a recall of 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... on 2020-01-13. FDA classified it as Class II and gives the reason 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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1345-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-13
Posted: 2020-02-21
Terminated: 2023-06-22
Recalling firm: Philips North America LLC
Product: 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
Product code: MWJ Electrocardiograph, Ambulatory (Without Analysis)
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.
Root cause tag: design
FDA root cause: Device Design
Action: Philips Issued Medical Device Correction letter dated January 13, 2020 to U.S. customers, via priority mail. Philips Market Organizations are responsible for distributing the letters outside of the U.S. Instructions to Customer Philips is asking customers to follow the Action to be Taken by Customer/User section of the CIL: Upon receipt of this notification, promptly locate and isolate affected devices. The steps in the Instructions on Clearing Error 602 below may be used to reset your devices. Customers can contact Philips should they choose not to reset the device on their own. For information or support contact: your local Philips representative or call us at 1 -800-722-9377.
Quantity in commerce: 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
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1345-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1345-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-21

Product code MWJ

K071733Class IIDl900 Series Holter RecorderBraemar, Inc. / cleared 2007-07-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)