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Defibtech, LLC recalls Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), D
Recalled May 7, 2025 · FDA recall Z-1690-2025 · 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
43 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
Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), DCF-E110SG-FR/1 (French language), DCF-E110SG-IT/1 (Italian language)
Manufacturer(s)
Defibtech, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →