FDA recall Z-1312-2023

Product

DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest

Reason for recall

A component of a sub-assembly used in the affected AEDs had not undergone durability and reliability testing, and if a malfunction occurs, therefore the device could fail to deliver therapy.

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2023-02-14

Report date

2023-04-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Guilford, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1312-2023