FDA-Device2025-05-07Class II
Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German language)
Defibtech, LLC
Hazard
It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).
Sold states
International Only: Switzerland.
Affected count
1 unit (OUS only)
Manufactured in
741 Boston Post Rd Ste 201, N/A, Guilford, CT, United States
Products
Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German language)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1693-2025Don't want to check this manually?
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