FDA-Device2025-05-07Class II
Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/English dual 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
13 units (OUS only)
Manufactured in
741 Boston Post Rd Ste 201, N/A, Guilford, CT, United States
Products
Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/English dual language)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1691-2025Don't want to check this manually?
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