Date Initiated by Firm | January 13, 2020 |
Create Date | February 21, 2020 |
Recall Status1 |
Terminated 3 on June 22, 2023 |
Recall Number | Z-1345-2020 |
Recall Event ID |
84879 |
510(K)Number | K071733 |
Product Classification |
Electrocardiograph, ambulatory (without analysis) - Product Code MWJ
|
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 |
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. |
Recalling Firm/ Manufacturer |
Philips North America, LLC 3000 Minuteman Rd Andover MA 01810-1032
|
For Additional Information Contact | SAME 978-659-3000 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = MWJ
|