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Defibtech, LLC recalls Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E22
Recalled May 7, 2025 · FDA recall Z-1691-2025 · Defibtech
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). · FDA Class II
Units
13 units (OUS only)
Sold at
International Only: Switzerland.
Description
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).
Product
Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/English dual language)
Manufacturer(s)
Defibtech, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →