FDA recall Z-2393-2020

Defibtech, LLC · Class II · device

Product

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

Worldwide distribution - US Nationwide distribution and the countries of Australia, Canada, France, Malaysia, Mauritius, Netherlands, Thailand, United Arab Emirates.

Key facts

Status
Terminated
Initiation date
2020-04-27
Report date
2020-06-24
Termination date
2021-01-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Guilford, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2393-2020