FDA-Device2023-04-05Class II
DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest
Defibtech, LLC
Hazard
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.
Sold states
US Nationwide distribution.
Affected count
29 units
Manufactured in
741 Boston Post Rd, Suite 201, Guilford, CT, United States
Products
DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1312-2023Don't want to check this manually?
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