Z-2393-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 24, 2020
- Initiation Date
- April 27, 2020
- Termination Date
- January 8, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 860
Product Description
DDU-2400EN Lifeline PRO, UDI 00815098020270 - Product Usage: Automated External Defibrillators (AED) are indicated for use on victims of sudden cardiac arrest (SCA) who are: - unconscious and unresponsive, not breathing or not breathing normally.
Reason for Recall
A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an affected device to fail to delivery shock, and/or to fail to deliver shock in range.
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the countries of Australia, Canada, France, Malaysia, Mauritius, Netherlands, Thailand, United Arab Emirates.
Code Information
Serial Number 400101322