Philips DigiTrak XT Holter Recorder Software version recall
Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The DigiTrak XT Recorder is available in four different configurations.…
Why was Philips DigiTrak XT Holter Recorder Software version 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The DigiTrak XT Recorder is available in four different configurations.…
- Recalling firm
- Philips North America, LLC
- Quantity
- 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
- Recall date
- March 4, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)